A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Sol… (NCT05458219) | Clinical Trial Compass
RecruitingPhase 1
A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
United States, Australia470 participantsStarted 2022-10-26
Plain-language summary
This is a Phase Ia/Ib, multicenter, open-label, first-in-human study to evaluate the safety, tolerability, PK, and efficacy of IBI343 in participants with locally advanced unresectable or metastatic solid tumors. It is planned to be carried out in different countries or regions such as China, Australia and US.
There are three parts in phase Ia. Part 1 includes dose escalation and expansion phase and part 2 is designed for dose optimization for IBI343 monotherapy.
Part 3 1L G/GEJ AC and 1L PDAC cohorts will include an initial safety lead-in stage to confirm the tolerability of IBI343 in combination with chemotherapy in 1L PDAC and G/GEJ AC, followed by a randomized dose-optimization stage designed to further characterize safety, pharmacokinetics, and preliminary efficacy to inform selection of the recommended Phase 3 dose.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Has signed written Informed Consent Form (ICF), willing and able to comply with protocol-specified visits and related procedures.
✓. Phase Ia dose escalation phase, Phase Ia part 3 1L G/GEJ AC and 1L PDAC cohorts Safety Lead-in stage: Has at least 1 evaluable lesion according to RECIST v1.1; Phase Ia dose expansion and dose optimization phase, Phase Ia part 3 1L G/GEJ AC and 1L PDAC cohorts Dose optimization stage, Phase Ib: Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors RECIST v1.1.
✓. Age ≥ 18 years, of either sex.
✓. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
✓. Has an expected survival ≥ 12 weeks.
✓. Has adequate bone marrow and organ function. Defined as:
✓. Female participants of childbearing potential or male participants whose partners are female of childbearing potential are required to use effective contraceptive measures throughout the treatment period and for 6 months after the final treatment period.
✓. Participants with histopathologically confirmed unresectable locally advanced or metastatic malignant solid tumors that have failed or were intolerant to standard therapy or for whom no standard therapy is available.
✕. Is participating in another interventional clinical study other than an observational (non-interventional) clinical study or is in the survival follow-up phase of an interventional study.
✕. Has received the last dose of antineoplastic therapy within 4 weeks or 5 half-lives of an antineoplastic therapy (whichever is shorter) prior to the first dose of study drug.
✕. Plans to receive other anti-tumor therapy during treatment with the study drug \[palliative radiotherapy for symptomatic relief (e.g., pain) that does not affect response assessment is allowed\].
✕. Has received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug.
✕. Toxicities due to prior therapy that have not recovered to Grade 0 or 1 per NCI CTCAE v5.0 prior to the first dose of study drug (excluding alopecia, asthenia, hyperpigmentation, and other conditions with no safety risk per the judgment of the investigator).
✕. Has undergone major surgical procedure (craniotomy, thoracotomy, laparotomy or others per the investigator, excluding needle biopsy) or has unhealed wounds, ulcers, or bone fracture within 4 weeks prior to the first dose of study drug; Or plans to undergo major surgery during the study period; Note: Local surgical treatment of isolated lesions for palliative purposes is acceptable.
✕. Has gastric pyloric obstruction and/or persistent recurrent vomiting (≥ 3 episodes in 24 hours).
✕. Has a history of gastrointestinal perforation and/or fistula within 6 months that has not resolved surgically prior to the first dose of study drug.
Timeframe: Through study completion, up to 2 years
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Number of participants with abnormal vital signs
Timeframe: Through study completion, up to 2 years
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Number of participants with abnormal vital signs
Timeframe: Through study completion, up to 2 years
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Number of participants with abnormal vital signs
Timeframe: Through study completion, up to 2 years
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Number of participants with abnormal laboratory tests results
Timeframe: Through study completion, up to 2 years
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Number of participants with abnormal laboratory tests results
Timeframe: Through study completion, up to 2 years
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Number of participants with abnormal laboratory tests results
Timeframe: Through study completion, up to 2 years
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Number of participants with abnormal laboratory tests results
Timeframe: Through study completion, up to 2 years
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Number of participants with abnormal laboratory tests results
Timeframe: Through study completion, up to 2 years
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Number of participants with abnormal laboratory tests results
Timeframe: Through study completion, up to 2 years