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RecruitingLast updated: 4 January 2024

This study aims to determine how safe, tolerable and effective a drug called aplitibart is when given alone, and in combination with other drugs such as chemotherapy and targeted therapy, in people with relapsed, refractory or newly diagnosed cancersAn Open-label, Multicenter, Phase 1a/1b Study of Aplitibart (IGM-8444) as a Single Agent and in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers

Clinical summary

Summary

This study has two phases each with multiple arms: Phase 1a (non-randomised) and Phase 1b (randomised).

Phase 1a has the following experimental treatment arms:

  • Aplitibart will be administered intravenously as a single agent on an alternate dosing scedule
  • Aplitibart will be administered intravenously in combination with FOLFIRI chemotherapy with or without Bevacizumab targeted therapy.
  • Aplitibart will be administered intravenously in combination with Birinapant which will also be administered intravenously.
  • Aplitibart will be administered intravenously in combination with Venetoclax targeted therapy.
  • Aplitibart will be administered intravenously in combination with Docetaxel and Gemcitabine chemotherapy.
  • Aplitibart will be administered intravenously in combination with Venetoclax targeted therapy and Azacitidine chemotherapy. 

Phase 1b has the following experimental treatment arms:

  • Aplitibart will be administered intravenously in combination with FOLFIRI chemotherapy and Bevacizumab targeted therapy.
  • Standard of Care FOLFIRI chemotherapy + Bevacizumab targeted therapy will be administered intravenously. 

Conditions

This trial is treating patients with relapsed, refractory or newly diagnosed cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

IGM Biosciences, Inc.

Scientific Title

An Open-label, Multicenter, Phase 1a/1b Study of Aplitibart (IGM-8444) as a Single Agent and in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers

Eligibility

Inclusion

  • Age ≥ 18 years at time of signing ICF
  • ECOG Performance Status of 0 or 1
  • Histologic documentation of incurable, locally advanced or metastatic tumor of the type being evaluated in individual cohorts.
  • Adequate hepatic and renal function and adequate bone marrow reserve function.
  • For combination cohorts, participants must be eligible to receive the chemotherapy or targeted agent.
  • Ph1a only: No more than three prior therapeutic regimens.
  • Ph1b only: Must be FOLFIRI naïve participants and must have received only 1 prior therapeutic regimen administered for the treatment of cancer in the advanced/metastatic setting - OR - FOLFIRI naïve participants that only received adjuvant therapy who progressed within six months after completing adjuvant therapy, and are confirmed to have locally advanced/metastatic disease

Exclusion

  • Inability to comply with study and follow-up procedures.
  • Prior DR5 agonist therapy.
  • Concomitant use of agents well-known to cause liver toxicity.
  • Concomitant use of anti-cancer agents
  • Palliative radiation to bone metastases within 2 weeks prior to Day 1.
  • Major surgical procedure within 4 weeks prior to Day 1.
  • Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible.
  • Prior use of any chemotherapeutic agent or small molecule inhibitors (SMI) within 2 weeks or 5 half-lives, prior to the first dose of study treatment
  • Treatment with a monoclonal antibody, or any other anticancer agent (including biologic, experimental, or hormonal therapy) investigational or otherwise, that is not chemotherapy or a SMI, within 4 weeks or five half-lives prior to first dose of study treatment.
  • Ph1b: Participants who have previously received FOLFIRI treatment in the adjuvant, advanced, or metastatic disease setting

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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