Health TrialsbyHealthPanel

A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

ConditionsSolid TumorsAdvanced Solid TumorsMetastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation

About this trial

To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old

Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol.

Part 1: Participants must have experienced disease progression after treatment with, be intolerant to, or be ineligible for, or refused available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit. Part 2: depending on cohort, participants may have received or not prior treatment for the malignancy under study.

ECOG performance status score of 0 or 1.

Disqualifiers

Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years.

Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.

Has active autoimmune disease requiring systemic immunosuppression with corticosteroids.

Brain or CNS metastases untreated or that have progressed.

Trial design

Design model

Sequential

Treatments tested in this trial

  • INCA33890

    Drug

    INCA33890 will be administered at protocol defined dose.

  • bevacizumab

    Drug

    Bevacizumab will be administered at protocol defined dose.

  • FOLFIRI

    Drug

    FOLFIRI will be administered at protocol defined dose.

  • FOLFOX

    Drug

    FOLFOX will be administered at protocol defined dose.

  • Cetuximab

    Drug

    Cetuximab will be administered at protocol defined dose.

  • ADG126

    Drug

    ADG126 will be administered at protocol defined dose.

Treatment groups

570 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: Part 1a - Dose Escalation MonotherapyExperimental treatment 1 intervention
Group B: Part 1b-Dose Expansion MonotherapyExperimental treatment 1 intervention
Group C: Part 2a - Dose Escalation Combination Therapy - Group 1Experimental treatment 2 interventions
Group D: Part 2a - Dose Escalation Combination Therapy - Group 2Experimental treatment 3 interventions
Group E: Part 2a - Dose Escalation Combination Therapy - Group 3Experimental treatment 3 interventions
Group F: Part 2a - Dose Escalation Combination Therapy - Group 4Experimental treatment 2 interventions
Group G: Part 2a - Dose Escalation Combination Therapy - Group 5Experimental treatment 2 interventions
Group H: Part 2b - Dose Expansion Combination Therapy - Group 1Experimental treatment 2 interventions
Group I: Part 2b - Dose Expansion Combination Therapy - Group 2Experimental treatment 3 interventions
Group J: Part 2b - Dose Expansion Combination Therapy - Group 3Experimental treatment 3 interventions
Group K: Part 2b - Dose Expansion Combination Therapy - Group 4Experimental treatment 2 interventions
Group L: Part 2b - Dose Expansion Combination Therapy - Group 5Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicities (DLTs)

Time frame
Up to 28 days
2

Treatment Emerging Adverse Events (TEAEs)

Time frame
Up to 2 years
3

TEAEs leading to dose modification or discontinuation

Time frame
Up to 2 years

Secondary outcomes

1

Objective response Rate

Time frame
2 years
2

Disease Control Rate

Time frame
2 years
3

Duration of Response

Time frame
2 years
4

Pharmacokinetics Parameter : Cmax of INCA33890

Time frame
Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

Other outcomes

Sponsors and contacts

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

Incyte Corporation

Lead sponsor

Source ClinicalTrials.gov
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