A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of INCB Combinations in Advanced Solid Tumors

  • STATUS
    Recruiting
  • sponsor
    Incyte Corporation
Updated on 8 December 2020
Duke Cancer Institute (119.4 mi away) Contact
+10 other location
solid tumors
solid tumor

Summary

A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of INCB Combinations in Advanced Solid Tumors

Description

This is an open-label, multicenter, Phase 1b platform study in subjects with advanced or metastatic solid tumors (Part 1a) and subjects with selected solid tumors (Part 1b and Part 2).

Two treatment groups (Group A and Group B) will be evaluated.

Part 1a utilizes a 3+3 design to evaluate pembrolizumab and INCB combinations in advanced solid tumors. 

  • Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib (INCB039110) in combination with pembrolizumab (MK-3475) and
  • Group B will evaluate a PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum0 tolerated dose (MTD) or PAD and recommend a dose for the Part 1b safety expansion with each combination.

Once the recommended dose has been identified in Part 1a, subjects with select solid tumor types will be enrolled into safety expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b) for each combination. 

Part 2 utilizes a Simon 2-Stage design to evaluate INCB050465 in combination with pembrolizumab in patients with small cell lung cancer (SCLC) and a 1 stage design to evaluate the combination in patients with non-small cell lung cancer (NSCLC) and urothelial cancer (UC).

 

Details
Condition Solid Tumors
Clinical Study IdentifierTX144824
SponsorIncyte Corporation
Last Modified on8 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, age 18 years or older
Willingness to provide written informed consent for the study
Part 1a: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (including subject refusal or intolerance)
Part 1b: Subjects with endometrial cancer, gastric cancer, head and neck squamous cell carcinoma, melanoma, microsatellite unstable colorectal cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, renal cell carcinoma, triple negative breast cancer, or transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment
Part 1b: Must have documented confirmed disease progression on a prior programmed cell death-1 (PD-1) pathway targeted agent or must be PD-1 pathway-targeted treatment naive
Has baseline tumor biopsy specimen available or willingness to undergo a pre-treatment tumor biopsy to obtain the specimen
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

Laboratory parameters not within the protocol-defined range
Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug
Received an immune-suppressive based treatment for any reason within 14 days prior to the first dose of study treatment
Has no recovered from toxic effect of prior therapy to < Grade 1
Active or inactive autoimmune process
Has received a live vaccine within 30 days of planned start of study therapy
Active infection requiring systemic therapy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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