First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors

Conditions

• Cancer, Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• IBI308 — DRUG
• IBI308\Cisplatinum\Pemetrexed — DRUG
• IBI308\cisplatin\gemcitabine — DRUG
• IBI308\oxaliplatin\capecitabine — DRUG
• IBI308\etoposide\cisplatin — DRUG
• IBI308\irinotecan\5-FU — DRUG

Study Details

The purpose of this study is to determine the safety, tolerability and efficacy of IBI308 monotherapy or in combination with chemotherapy in patients with certain types of advanced solid tumors. Another purpose is to determine the pharmacokinetics, pharmacodynamics and immunogenicity of IBI308.

Key Dates

Start date

Oct 19, 2016

Status verified

Sep 2022

Primary completion

Sep 30, 2020

Completion

Sep 30, 2020

Study Design

Enrollment

233 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1a
  Participants will receive IBI308 1mg/kg, 3mg/kg or 10mg/kg intravenous every 2 weeks, or 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity. Drug: IBI308
• Experimental: Phase 1b Cohort A
  Participants will receive IBI308 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308
• Experimental: Phase 1b Cohort B
  Participants will receive IBI308 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308
• Experimental: Phase 1b Cohort C
  Participants will receive IBI308 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308
• Experimental: Phase 1b Cohort D
  Participants will receive IBI308 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308/Cisplatinum/Pemetrexed
• Experimental: Phase 1b Cohort E
  Participants will receive IBI308 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308\\gemcitabine\\cisplatin
• Experimental: Phase 1b Cohort F
  Participants will receive IBI308 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308\\oxaliplatin\\capecitabine
• Experimental: Phase 1b Cohort G
  Participants will receive IBI308 200mg in combination with cisplatin 75mg/m2 intravenously and etoposide 100mg/m2 intravenously day 1 to 3 of every 3 weeks for upto 6 cycles. Those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308\\etoposide\\cisplatin
• Experimental: Phase 1b Cohort H
  Participants will receive IBI308 200mg in combination with irinotecan 125mg/m2 intravenously day 1and 8 and 5-FU 1000mg/m2 intravenously day 1 to 3 of every 3 weeks for upto 6 cycles.Those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308\\irinotecan\\5-FU

Primary Outcome Measure

Number of Participants Experiencing Dose-limiting Toxicities (DLTs) [ Time Frame: Up to 28 days in Cycle 1 ]