CompletedPhase 1/2

Safety and Efficacy of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Selected Advanced Solid Tumors

China68 participantsStarted 2019-12-20

Plain-language summary

A multicenter, open-label, phase 1b/2 study to evaluate the safety and efficacy of AK104, a PD-1 and CTLA-4 bispecific antibody, in selected advanced solid tumors.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Written and signed informed consent.
✓. Male or female, age ≥ 18 years and ≤75, at the time of study entry.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
✓. Estimated life expectancy of ≥3 months.
✓. Histologically or cytologically documented advanced or metastatic melanoma and other selected advanced solid tumors.
✓. Subjects must have at least one measurable lesion per RECIST v1.1.
✓. Available archived tumor tissue sample to allow for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use , the subject must consent and undergo fresh tumor biopsy (biopsy at acceptable risk as judged by the investigator).
✓. Adequate organ functions.

Exclusion criteria

✕. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
✕. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
✕. Prior exposure to anti-tumor therapies, including systematic chemotherapy, radiotherapy, immunotherapy, hormone therapy, targeted therapy (within 2 weeks before the first administration of the study treatment), and systematic immune-modulators (including but not limited to interferon, interleukin-2 and tumor necrosis factor) within 4 weeks prior to the first administration of the study treatment. Prior exposure to Chinese herbal medicine or proprietary Chinese medicine with anti-tumor functions within 2 weeks prior to the first administration of the study treatment.
✕. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria. Hair loss is excluded.
✕. For subjects previously treated with anti-PD-1, PD-L1 or other immunotherapies: (1) Subjects have experienced a toxicity that led to permanent discontinuation of prior immunotherapy. (2) All AEs while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening for this study. (3) Subjects have required the use of additional immunosuppression other than corticosteroids for the management of an AE, or have experienced recurrence of an AE if re-challenged with corticosteroids while receiving prior immunotherapy.
✕. Subjects with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with some exceptions.
✕. Active or previously documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis or chronic diarrhea).
✕. Prior use of systematic corticosteroid (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to the first administration of the study treatment.

What they're measuring

Anti-tumor activity of AK104 using objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator

Timeframe: Up to 2 years

Trial details

NCT IDNCT04172454

SponsorAkeso

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-17

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