A Phase 1, Open-Label, Dose Escalation and Expansion Study of ASP1012, an Oncolytic Virus, in Participants With Locally Advanced or Metastatic Solid Tumors

ASP1012 is a type of virus called an oncolytic virus which is used to treat some cancers.
ASP1012 was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. It also makes the cancer cells visible to the immune system which will fight the cancer cells.
Before ASP1012 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This will help find a suitable dose for future studies and check for potential medical problems from the treatment.
In this study, ASP1012 is being tested in humans for the first time. ASP1012 has already been tested in the laboratory and in animals. This is the standard way new potential treatments are developed.
People in this study will be adults whose tumor has either grown outside of the area where it started (locally advanced) or it has spread to other parts of the body (metastatic). They will receive ASP1012. Also, some people will receive ASP1012 with pembrolizumab, an approved medicine.
There are 2 main aims of this study. The first is to learn if people with certain solid tumors can tolerate different doses of ASP1012. The second is to find a suitable dose of ASP1012.
This study will be in 3 parts.
Part 1 is called Dose Escalation. People with locally advanced or metastatic tumors can take part. They will have been previously treated with all available standard cancer therapies. Different small groups of people will receive lower to higher doses of ASP1012.
For each dose, any medical problems will be recorded. This will help to find suitable doses of ASP1012 to use in Parts 2 and 3 of the study. The first group will receive the lowest dose of ASP1012. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP1012. The panel will do this for each group until all groups have taken ASP1012 or until suitable doses have been selected for Parts 2 and 3.
Part 2 is called Dose Expansion. 3 groups will take part: people with previously-treated melanoma (a type of skin cancer) that have not responded to their treatment (refractory) or their cancer has come back (relapsed), people with newly-diagnosed or untreated melanoma, and people with previously-treated solid tumors. People with previously-treated melanoma will receive ASP1012 at the dose worked out from Part 1. People with previously-treated solid tumors will receive ASP1012 with pembrolizumab. The first few people will receive ASP1012 at a lower dose than the dose worked out from Part 1, to check the safety of the treatments being given together. If there are no safety issues: the next people in the solid tumor group will receive ASP1012 at the dose worked out from Part 1, with pembrolizumab; also people with untreated melanoma will receive ASP1012 at the dose worked out from Part
1, with pembrolizumab.
Part 3 is also a Dose Expansion for people with other specific cancers. These are stomach cancer, ovarian cancer, or colorectal cancer. If people with certain tumors respond well in Parts 1 and 2 of the study, other people with this same type of tumor can also take part in Part 3.
For all parts of the study, ASP1012 will be given through a vein. This is called an infusion.
Each treatment cycle is 21 days long. People will start with 3 treatment cycles. People in the study may receive extra treatment cycles, if they respond well to treatment. People with melanoma who are receiving ASP1012 with pembrolizumab will not be offered the extra treatment cycles. People can stop leave the study early if: they have medical problems from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment.
People will visit the clinic on certain days during their treatment. Some visits will be virtual or by phone. During all clinic visits, the study doctors will check for any medical problems from ASP1012. They will also check vital signs. Vital signs include temperature, pulse, breathing rate, the amount of oxygen in the blood, and blood pressure. At some visits, other checks will also include a medical examination, and an electrocardiogram (ECG) to check the heart rhythm, blood draws and urine samples for testing. A tumor sample, if available, will be taken during the first treatment cycle. People will have imaging scans and have blood draws for testing every 6 weeks during and after treatment. This will stop if they leave the study early.
People will visit the clinic within 7 days and 30 days after stopping treatment. At both visits, the study doctors will check for any medical problems from ASP1012. Other checks will include a medical examination, blood draws and urine samples for testing and checking vital signs. An ECG will also be done at the 7-day visit. After the 30-day visit, clinic staff will phone people in the study every 12 weeks to check the condition of their cancer for up to 1 year.

开始日期2024-05-15

申办/合作机构

Astellas Pharma Global Development, Inc.

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2024-10-09

·PipelineReview

KaliVir Immunotherapeutics Doses First Patient in Phase 1/1b Trial of VET3-TGI for Incurable, Advanced, Solid Tumors

Novel oncolytic immunotherapy being evaluated via IV and intratumoral delivery, both as monotherapy and in combination with checkpoint inhibitors PITTSBURGH, PA, USA I October 08, 2024 I KaliVir Immunotherapeutics, Inc. , a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy therapeutics, today announced that the first patient has been dosed in its STEALTH-001 study, a Phase 1/1b clinical trial of VET3-TGI for patients with incurable, advanced solid tumors. VET3-TGI is a novel oncolytic immunotherapy which is designed to target and selectively kill tumor cells while also expressing an immuno-stimulatory transgene payload consisting of interleukin-12 and a TGFbeta inhibitor. “The dosing of our first patient in the STEALTH-001 study marks a significant milestone for KaliVir and our innovative VET3-TGI program,” said James Burke, M.D., Chief Medical Officer of KaliVir Immunotherapeutics. “The unique engineering of this platform to selectively target the tumor even in the face of anti-viral immunity holds great promise in delivering potent immune stimulatory cargo intravenously in patients with advanced solid tumors. Both VET3-TGI monotherapy and combination with checkpoint inhibition will be explored in this initial study.” About the STEALTH-001 Clinical Trial STEALTH-001 (ClinicalTrials.gov No. NCT06444815) is a dose escalation and expansion study with VET3-TGI administered by direct injection into tumor(s) or by intravenous infusion. The dose escalation will determine the highest tolerated dose of VET3-TGI when injected directly into the tumor(s), given intravenously and when combined with the checkpoint blockade. Once the maximum tolerated dose is found for each of these groups, expansion cohorts will be initiated to further evaluate the safety and efficacy of VET3-TGI. The study is enrolling patients with pathologically confirmed, advanced, unresectable or metastatic solid tumors. “VET3-TGI has the potential to reshape our approach to treating advanced tumors and provide a new path forward for patients who urgently need better treatment options,” said Jorge Nieva, M.D., Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and Section Head of Lung and Head/Neck Tumors at the Norris Comprehensive Cancer Center and a member of KaliVir’s Medical Advisory Board. “This is a pivotal milestone and I look forward to seeing the continued progress of VET3-TGI as a monotherapy and in combination with checkpoint inhibitor therapy.” About KaliVir Immunotherapeutics, Inc. KaliVir Immunotherapeutics is a clinical-stage biotechnology company at the forefront of developing next-generation oncolytic immunotherapies. By harnessing the unique advantages of the vaccinia platform, KaliVir engineers optimized viral backbones to create innovative candidates for cancer treatment. The Company’s proprietary Vaccinia Enhanced Template (VET™) platform integrates multiple genetic modifications, allowing for the systemic delivery of oncolytic vaccinia candidates and the targeted expression of therapeutic transgenes within tumors. The Company is actively expanding its pipeline using the VET™ platform, with its capabilities validated through strategic global partnerships with Astellas Pharma and Roche. Currently, the Company has two product candidates in Phase 1 clinical trials: ASP1012, exclusively licensed and led by Astellas Pharma, and its internal lead candidate, VET3-TGI. With multiple therapeutic candidates progressing through clinical development, KaliVir is positioned as a leader in innovative cancer therapies. Headquartered in Pittsburgh, Pennsylvania, KaliVir is committed to revolutionizing cancer treatment. For more information, visit kalivir.com . SOURCE: KaliVir Immunotherapeutics

免疫疗法临床1期

2024-07-01

·BioSpace

KaliVir Immunotherapeutics Announces FDA Clearance of Investigational New Drug (IND) for Oncolytic Immunotherapy VET3-TGI for Solid Tumors

Phase 1/1b study of VET3-TGI, alone and in combination with checkpoint inhibitor therapy, for advanced solid tumors PITTSBURGH--(BUSINESS WIRE)-- KaliVir Immunotherapeutics, Inc., a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, today announced that the FDA has cleared the Investigational New Drug (IND) application for the STEALTH-001 study of VET3-TGI in patients with incurable, advanced solid tumors. VET3-TGI is a novel oncolytic immunotherapy which in nonclinical studies specifically targets and preferentially kills tumor cells directly while stimulating anti-cancer immunity by expressing its therapeutic payload consisting of the transgenes for interleukin-12 and a TGFbeta inhibitor. The Phase 1/1b study (ClinicalTrials.gov ID NCT06444815) will evaluate the safety pro efficacy of VET3-TGI when administered through intravenous infusion or intratumoral injection in patients with advanced, incurable solid tumors. The trial will assess VET3-TGI both as a monotherapy and in combination with checkpoint inhibitor therapy. “The initiation of this Phase 1/1b clinical study marks a pivotal moment in our continued journey to redefine cancer treatment with oncolytic virus therapy and combat advanced, unresectable or metastatic solid tumors,” said Helena Chaye, Ph.D., CEO of KaliVir Immunotherapeutics. “This marks our second initiation of a clinical trial from the VET platform, having announced in 2023 the progress with ASP1012 exclusively licensed to Astellas. We remain fully committed to pushing the boundaries on what is possible with cancer therapies and develop safer, more effective options that have the potential to transform the treatment landscape of oncology.” About KaliVir Immunotherapeutics, Inc. KaliVir Immunotherapeutics is a privately held biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs. The company has developed a unique vaccinia virus-based platform, Vaccinia Enhanced Template “VET” Platform, that can generate potent novel oncolytic vaccinia viruses with modifications to maximize viral replication and to enhance intravenous delivery and spread. VET™ platform utilizes the large transgene capacity of the vaccinia virus to deliver therapeutics matched to tumor immunophenotypes to stimulate patients’ immune systems and modify the tumor microenvironment. KaliVir’s oncolytic virus candidates are designed to be safe, potent and systemically deliverable to treat cancer patients across multiple tumor types. KaliVir has separate collaborations with Roche and Astellas Pharma to design and generate novel oncolytic vaccinia viruses derived from the VET™ platform. In addition, Astellas entered into a world-wide exclusive license to develop and commercialize KaliVir’s initial lead clinical candidate VET2-L2 oncolytic vaccinia virus. KaliVir is currently advancing multiple therapeutic candidates toward the clinic. For more information, please visit kalivir.com.

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2024-02-28

·BioSpace

C-Suite Shuffle: ReNAgade, Adaptimmune, Vittoria and More

Pictured: A red illustration of a businessman walking through a door/iStock, lerbank Welcome to the first in a regular series of rundowns of people coming and going from the executive positions in the biopharma companies that BioSpace covers. This column will highlight the hired, fired, retired, promoted or resigning, and even those personally named in lawsuits. The big news of last week is that Richard Gonzalez will retire in July after 11 years as CEO of AbbVie, after helping AbbVie navigate the U.S. patent cliff for its blockbuster anti-inflammatory drug Humira. And just yesterday, we learned that ReNAgade Therapeutics, featured in this year’s NextGen list, is hiring its first-ever chief science innovation officer just under a year after the company’s launch. The fact that ReNAgade did not hire for this position sooner highlights a trend we’ve noticed in the industry toward leaner C-suites. It will be interesting to track whether this continues. Feb. 27 ReNAgade Therapeutics, which placed 6th in BioSpace’s 2024 NextGen class, hired former Moderna Therapeutics R&D boss Joe Bolen as its first chief science innovation officer. The company launched in May 2023 with the goal of building an integrated therapeutic platform that can provide all elements needed to produce RNA therapeutics. Feb. 27 Adaptimmune is bringing back Cintia Piccina as chief commercial officer, effective March 18. Piccina, who served in this role from January 2022 to March 2023, will lead the commercialization of afami-cel, an engineered TCR T cell therapy targeting solid tumors in advanced synovial sarcoma. The American-British firm has an Aug. 4 PDUFA date for afami-cel, formerly called ADP-A2M4CD8. Feb. 27 Vittoria Biotherapeutics has brought in Rosemary Mazanet to serve as chief medical officer. Mazanet will lead clinical development strategy and operations for the startup CAR T therapies developer, which recently received FDA clearance to initiate a Phase I clinical trial for its lead candidate, VIPER-101, a potential treatment for relapsed or refractory T cell lymphoma. Feb. 27 Domain Therapeutics has elevated Stephan Schann to the position of chief scientific officer. Formerly vice president of research, Schann will lead R&D and pipeline development for the multinational company, which is developing a pipeline of targeted cancer immunotherapies. Feb. 22 The Pharmaceutical Research and Manufacturers of America (PhRMA) tapped Gilead Sciences CEO Daniel O’Day to be its new board chair, succeeding Novartis CEO Vas Narasimhan. Pfizer CEO Albert Bourla and Sanofi CEO Paul Hudson will serve alongside O’Day, becoming PhRMA’s board chair-elect and treasurer. The industry powerhouse is navigating a rare string of setbacks in terms of membership and executive losses while it also puts up a united front against the Medicare Drug Price Negotiation Program under the Inflation Reduction Act. Feb. 22 Ocular Therapeutix announced several executive-level appointments, notably elevating Jeffrey Heier from director and advisor to chief scientific officer. The news coincided with Ocular securing a $325 million private placement, which the company will apply to development of Axpaxli (axitinib intravitreal implant) for treatment of wet age-related macular degeneration. Feb. 21 AbbVie announced that CEO Richard Gonzalez will retire July 1. He will be succeeded by current President and COO Robert Michael. Gonzalez, who has helmed AbbVie since its 2013 spinoff from Abbott Laboratories, will become executive chairman. Gonzalez’s departure comes as AbbVie has been active in the M&A space, including its $10 billion buy of ImmunoGen in November 2023 and the $8.7 billion deal for Cerevel Therapeutics in December 2023. In an SEC filing this month, Cerevel reported that the company and AbbVie were handed a request for additional information and documentary materials (second request) from the Federal Trade Commission regarding the regulator’s review of the merger. Gonzalez also helped AbbVie navigate the U.S. patent cliff for its blockbuster anti-inflammatory drug Humira, helping the company to successfully withstand competition from low-cost biosimilars. Gonzalez said in AbbVie’s fourth quarter and full-year 2023 investor call that there was a connection between Humira’s loss of exclusivity (LOE) and his future with the company. “When we believe that we are comfortable, we’ve navigated the LOE, and the rest of the business is performing at high level, that’s the point at which we want to make the transition,” he said. Feb. 21 Narcan (naloxone) maker Emergent BioSolutions brought in Joseph Papa as president and CEO, replacing interim CEO Haywood Miller. Papa, former CEO of Bausch + Lomb, Valeant Pharmaceuticals and Perrigo, is reportedly tasked with engineering a turnaround, as he did at Bausch. Feb. 21 Saghmos Therapeutics named former FDA official Stephen Grant chief regulatory officer. The company is turning to Grant, former deputy director of the FDA Division of Cardiology and Nephrology, to help shepherd compounds including cardiorenal metabolic modulator ST-62516 (trimetazidine) through the review and approval process. Saghmos recently announced a notice of allowance for a U.S. patent on the drug, which seeks to reduce acute kidney injury and major adverse cardiac and kidney events during contrast procedures in patients with chronic kidney disease. Feb. 21 Sergio Santillana resigned as CMO of Ikena Oncology and was replaced by Caroline Germa, the company said. Ikena is currently in early-stage clinical trials with two candidate targeted cancer therapies, the IK-930 TEAD1 selective hippo pathway inhibitor and the IK-595 MEK-RAF “molecular glue.” Feb. 21 Synthekine announced several C-suite changes, including the promotion of Martin Oft to chief scientific officer and the hiring of Geoff Nosrati as chief business officer. The cytokine therapeutics startup is in a Phase I clinical trial with an orthogonal IL-2 and CD19 CAR-T combination therapy currently called STK-009 + SYNCAR-001. Last month, Synthekine formed a partnership with Sanofi US to develop and market IL-10 receptor agonists for inflammatory conditions. Feb. 21 James Burke left CG Oncology to become CMO at KaliVir Immunotherapeutics. Pittsburgh-based KaliVir recently obtained FDA IND clearance for a Phase I clinical study of ASP1012, a systemic oncolytic vaccinia virus therapy licensed to Astellas Pharma. The trial includes subjects with locally advanced or metastatic solid tumors. Feb. 20 Phil Pang, executive vice president and CMO of Vir Biotechnology, will step down at the end of March, the company said. Just last week, Vir reported that GSK decided to terminate a partnership to research, develop and commercialize Vir’s monoclonal antibodies for the prevention, treatment or prophylaxis of the influenza virus. Vir now will hold sole rights to its investigational flu therapies. Neil Versel is the business editor at BioSpace. You can reach him at neil.versel@biospace.com. Follow him on LinkedIn or X.

临床1期高管变更免疫疗法

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