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No longer recruiting (closed or complete)Last updated: 2 February 2024

This phase I trial is trying to understand how safe and tolerable a new targeted therapy is (AK117) for the treatment of adults with advanced cancers that have spread to other parts of the body and have not responded/able to have other treatmentA Phase 1, Multicenter, Open Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 in Subjects With Relapsed/Refractory Advanced or Metastatic Solid Tumors or Lymphomas

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

Eligible patients will receive 4 weekly infusions (Days 1, 8, 15, and 22) of AK117 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal

Conditions

This trial is treating people with advanced cancer or lymphoma

Eligibility

Inclusion

  1. Able to provide written and signed informed consent
  2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
  3. Life expectancy ≥12 weeks
  4. 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 or women of non-childbearing potential.
  5. Willing to receive blood transfusion(s) when so advised by the investigator.
  6. Adequate organ function.
  7. Subjects must have a histologically or cytologically confirmed advanced solid tumor that is refractory or relapsed to the current standard therapies or which no effective standard therapy is available.
  8. At least 1 measurable lesion according to RECIST v1.1

Exclusion

  1. Concurrent enrollment in another clinical study excluding observational trials
  2. Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study
  3. Active brain/central nervous system (CNS) metastases
  4. Active infections requiring systemic therapy within 2 weeks prior to the first dose of investigational product.
  5. Known history of HIV.
  6. Known active hepatitis B or C infections
  7. Active or prior documented autoimmune disease that may relapse.
  8. History of interstitial lung disease or non-infectious pneumonitis, except those induced by radiation therapies.
  9. History of defects in RBC production, or hemoglobin production or metabolism
  10. Patients with clinically significant cardio-cerebrovascular disease.
  11. History of severe hypersensitivity reactions to other mAbs.
  12. History of organ transplantation.
  13. Receiving any anticancer therapy targeting the CD47/SIRPα ; Anticancer small molecule targeted agent within 2 weeks prior to the first dose of the investigational product; Anticancer mAbs within 6 weeks prior to the first dose of investigational product or 5 half-lives (whichever is lesser); Other anticancer therapy within 4 weeks prior to the first dose of the investigational product;
  14. Subjects with a condition requiring systemic treatment with either corticosteroid (>10 mg daily doses)) or other immunosuppressive medications within 2 weeks prior to the first dose of investigational product.
  15. Received a live attenuated vaccine within 4 weeks prior to the first dose of investigational product.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You are currently being treated on a clinical trial.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Akeso

Scientific Title

A Phase 1, Multicenter, Open Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 in Subjects With Relapsed/Refractory Advanced or Metastatic Solid Tumors or Lymphomas

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