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RecruitingLast updated: 5 February 2024

This phase I trial is evaluating how safe and tolerable a new biological therapy (AK127) in combination with another biological therapy (AK104 or cadonilimab) in patients with advanced or metastatic solid cancers (excluding some blood cancers)A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumour Activity of AK127 in Combination With AK104 in Subjects With Advanced or Metastatic Solid Tumours

Clinical summary

Summary

This is an Early Phase 1a/1b dose-escalation and dose-expansion study with one experimental arm. In the dose escalation phase, participants will receive AK127 using the 3+3+3 model given with a fixed regimen of AK104. Both AK127 and AK104 will be administered via intravenous infusion. The dose expansion phase will open at the discretion of the Sponsor.

Conditions

This trial is treating patients with advanced or metastatic solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Akeso

Scientific Title

A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumour Activity of AK127 in Combination With AK104 in Subjects With Advanced or Metastatic Solid Tumours

Eligibility

Inclusion

  1. Written and signed informed consent
  2. In Phase 1a, patients with relapsed or refractory advanced solid malignancies
  3. In Phase 1b, patients must have received no more than three prior lines of systemic therapy
  4. Subject must have at least one measurable lesion according to RECIST Version1.1.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
  6. Available archived or fresh tumor tissue
  7. Adequate organ function.
  8. For dose-expansion cohorts (Phase 1b), subjects must be willing to provide two fresh biopsy samples (pre-treatment and on treatment), where clinically appropriate.
  9. Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product.

Exclusion

  1. History of severe hypersensitivity reactions to other mAbs.
  2. Subjects with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.
  3. Prior use of approved or investigational anti-TIGIT, anti-PVRIG, or anti-CD96 therapy
  4. Receiving any Other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.) within 4 weeks prior to the first dose of treatment
  5. Any major surgery within 4 weeks prior to the first dose of treatment
  6. Receiving agents with immunomodulatory effect within 2 weeks prior to the first dose of treatment.
  7. Active or prior documented inflammatory bowel disease
  8. History of organ transplant.
  9. History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies.
  10. Known active hepatitis B or C infections or history of HIV.
  11. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.
  12. Patients with severe heart and lung dysfunction.

Inclusion

  • Your cancer has not spread to other parts of the body.
  • 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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