Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors (NCT05909995) | Clinical Trial Compass
TerminatedPhase 1
Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors
Stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.
United States8 participantsStarted 2023-08-29
Plain-language summary
The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Prior systemic therapy, diagnoses and disease setting as follows:
* For Part 1 (dose escalation), and no history of treatment with anti-CTLA-4 or anti-PD-(L)1 therapy and one of the following,
* Unresectable or metastatic cutaneous melanoma, or
* Unresectable of metastatic Child-Pugh Class A NDD not eligible for surgical and/or locoregional therapy, or
* Intermediate or poor-risk advanced clear cell RCC, or
* MSI-H or dMMR metastatic CRC and able to provide fresh or archival tumor tissue for central confirmation of MSI-H or dMMR.
* For Part 2 (dose expansion), IO treatment -naïve, e.g., no prior receipt of an anti PD-1, anti-PD-L1 or PD-L1, anti-CTLA-4, GITR, LAG3, TIM3, OX-40, IL-2, 4-1BB or other immune modulator, and have not received prior systemic therapy and one of the following,
* Unresectable or metastatic Child-Pugh Class A HCC not eligible for surgical and/or locoregional therapy, or
* Intermediate - or poor-risk advanced clear cell RCC.
* ECOG performance score of 0 or 1.
* Life expectancy \> 3 months, in the opinion of the investigator.
* Histologically confirmed solid tumors with measurable disease per RECIST v1.1.
* Exception: HCC may be diagnoses based on cross-sectional multiphasic imagining using the AASLD criteria.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
* Known history of an additional malignancy.
* Central nervous system (CNS) metastases requiring treat…
What they're measuring
1
Occurence of DLTs
Timeframe: 2 Years
2
Incidence of TEAEs
Timeframe: 2 Years
3
Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs