Health TrialsbyHealthPanel

IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

ConditionUnresectable Locally Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

This is a phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3014 in participants with unresectable locally advanced or metastatic solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Participants with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;

2.Male or female participants ≥ 18 years old;

3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;

4.Anticipated life expectancy of ≥ 12 weeks;

Disqualifiers

1.Drugs and other treatments to be excluded;

2.Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to Investigators' opinion) prior to first administration of the study drug;

3.Prior use of Camptothecin-Derived agents (e.g., irinotecan, topotecan) or immune checkpoint inhibitor and documented adverse reaction which is severe and influence the safety assessment of participants.

4.Allergic or hypersensitive to other monoclonal antibodies and/or Camptothecin Derivative based therapy, or any ingredients of IBI3014;

Trial design

Design model

Single group

Treatments tested in this trial

  • IBI3014

    Drug

    12 mg/kg D1 IV Q3W

  • IBI3014

    Drug

    6 mg/kg D1 IV Q3W

  • IBI3014

    Drug

    1 mg/kg D1 IV Q3W

  • IBI3014

    Drug

    15 mg/kg D1 IV Q3W

  • IBI3014

    Drug

    9 mg/kg D1 IV Q3W

  • IBI3014

    Drug

    3 mg/kg D1 IV Q3W

  • IBI3014

    Drug

    20 mg/kg D1 IV Q3W

  • IBI3014

    Drug

    18 mg/kg D1 IV Q3W

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: IBI3014Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization

Number ofparticipants with adverse events (AEs)

Time frame
2 years after LPI
2

Dose limiting toxicity (DLT) of IBI3014 in Phase 1 dose escalation

The occurance of Dose limiting toxicity (DLT) per protocol to establish MTD or RDEs

Time frame
21 days after LPI
3

ORR per RECIST v1.1 in Phase 1 dose expansion and Phase 2 dose optimization

The investigator assessed ORR per RECIST v1.1

Time frame
2 years after LPI
4

The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization

Number ofparticipants with abnormal laboratorytests results

Time frame
2 years after LPI

Secondary outcomes

1

Efficacy of IBI3014

DOR, DoR, TTR, PFS as evaluated by investigator per RECIST v1.1 criteria and OS

Time frame
2 years after LPI
2

PK profile of IBI3014

area under the curve (AUC)

Time frame
2 years after LPI
3

Incidence and characterization of anti-IBI3014 antibodies

Rate of ADA and Nab

Time frame
2 years after LPI
4

PK profile of IBI3014

area under the Cmax

Time frame
2 years after LPI

Other outcomes

Sponsors and contacts

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

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov
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