Health TrialsbyHealthPanel

A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

ConditionLocally Advanced Unresectable or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IBI343

    Drug

    IBI343 will be administered intravenously (IV) on Day 1 of every 21-day cycle.

  • FOLFIRINOX/mFOLFIRINOX

    Drug

    FOLFIRINOX/mFOLFIRINOX will be administered IV Q2W on Days 1-3 every 2 weeks (14 days).

  • mFOLFOX

    Drug

    mFOLFOX will be administered IV Q2W on Days 1-3 every 2 weeks (14 days) in each cycle after IBI343

  • IBI343

    Drug

    IBI343 will be administered IV Q2W on Day1 (14 days).

Treatment groups

470 Participants
are divided into 2 treatment groups
Group A: 3 armsExperimental treatment 3 interventions
Group B: Single armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events(AEs), treatment emergent adverse event (TEAEs)，serious adverse events (SAEs)

Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.

Time frame
Up to 90 days after the last administration
2

Dose-limiting Toxicity (DLT)

DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Time frame
21 days after the first dose of IBI343
3

To determine RP2D of IBI343.

To determine RP2D of IBI343.

Time frame
Up to 2 years
4

ORR assessed by the investigator based on RECIST version 1.1.

ORR assessed by the investigator based on RECIST version 1.1.ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR)

Time frame
Up to 2 years

Secondary outcomes

1

maximum concentration (Cmax)

PK parameters maximum concentration (Cmax) of IBI343, total antibody, can will be determined.

Time frame
Up to 2 years
2

area under the curve (AUC)

PK parameters area under the curve (AUC) of IBI343, total antibody, exatecan will be determined.

Time frame
Up to 2 years
3

clearance rate (CL)

PK parameters clearance rate of IBI343, total antibody, exatecan will be determined .

Time frame
Up to 2 years
4

half-life (t1/2)

PK parameters half-life (t1/2) of IBI343, total antibody, exatecan will be determined .

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Fortvita Biologics (USA)Inc.

Collaborator

TigerMed

Collaborator

Source ClinicalTrials.gov
Apply now