Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCA33890 · 3 trials · 4 indications
Defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or death due to any cause.
Defined as ctDNA positive at baseline and change to ctDNA negative at 3 months.
| Arm | Type | Description |
|---|---|---|
| INCA33890 | EXPERIMENTAL | INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose. |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose. |
| Part 1a - Dose Escalation Monotherapy | EXPERIMENTAL | INCA33890 will be administered at the protocol-defined dose based on cohort assignment. |
| Part 1b-Dose Expansion Monotherapy | EXPERIMENTAL | INCA33890 will be administered at the protocol-defined dose based on cohort assignment. |
| Part 2a - Dose Escalation Combination Therapy - Group 1 | EXPERIMENTAL | INCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment. |
| Part 2a - Dose Escalation Combination Therapy - Group 2 | EXPERIMENTAL | INCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment. |
| Part 2a - Dose Escalation Combination Therapy - Group 3 | EXPERIMENTAL | INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment. |
| Part 2a - Dose Escalation Combination Therapy - Group 4 | EXPERIMENTAL | INCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment. |
| Part 2a - Dose Escalation Combination Therapy - Group 5 | EXPERIMENTAL | INCA33890 will be administered in combination with ADG126 at the protocol-defined dose based on cohort assignment. |
| Part 2b - Dose Expansion Combination Therapy - Group 1 | EXPERIMENTAL | INCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment. |
| Part 2b - Dose Expansion Combination Therapy - Group 2 | EXPERIMENTAL | INCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment. |
| Part 2b - Dose Expansion Combination Therapy - Group 3 | EXPERIMENTAL | INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment. |
| Part 2b - Dose Expansion Combination Therapy - Group 4 | EXPERIMENTAL | INCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment. |
| Part 2b - Dose Expansion Combination Therapy - Group 5 | EXPERIMENTAL | INCA33890 will be administered in combination with ADG126 at the protocol-defined dose based on cohort assignment. |
| Name | Type | Description |
|---|---|---|
| INCA33890 | DRUG | INCA33890 will be administered at protocol defined dose. |
| Placebo | DRUG | Placebo will be administered at protocol defined dose. |
| Bevacizumab | DRUG | Bevacizumab will be administered at protocol defined dose. |
| FOLFOX | DRUG | FOLFOX will be administered at protocol defined dose. |
| FOLFIRI | DRUG | FOLFIRI 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. |
Inclusion Criteria: * Stage IV colorectal adenocarcinoma not amenable to curative resection. * No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment...
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INCA33890 is an investigational cancer therapy being studied in colorectal cancer and other advanced or metastatic solid tumors. Its clinical program focuses on microsatellite stable colorectal cancer, including both early-stage disease after surgery and chemotherapy and first-line metastatic disease in combination with standard chemotherapy and bevacizumab.
INCA33890 is a small molecule designed to target TGFβR2 and PD-1, a dual-target approach written as TGFβR2xPD-1. By engaging both the TGF-beta receptor 2 pathway and the PD-1 immune checkpoint, the drug is intended to act on tumor and immune signaling in colorectal cancer and other solid tumors.
INCA33890 is being developed by Incyte Corporation, which trades on the Nasdaq under the ticker INCY. Incyte is the sponsor of the clinical program evaluating the drug in colorectal cancer and advanced solid tumors.
INCA33890 is in Phase 3 development. It is an investigational small molecule and has not been approved by the FDA. The Phase 3 study is evaluating it in first-line metastatic microsatellite stable colorectal cancer, and additional Phase 1 and Phase 2 studies are also ongoing.
INCA33890 is being studied in three registered trials. NCT07284849 is a recruiting Phase 3 trial in first-line metastatic microsatellite stable colorectal cancer. NCT05836324 is a recruiting Phase 1 trial in advanced or metastatic solid tumors, and NCT07823322 is a Phase 2 trial in circulating tumor DNA-positive stage II or III colorectal cancer after resection and chemotherapy.
The INCA33890 clinical program has a combined planned enrollment of about 1,310 participants across its three studies. The Phase 3 trial NCT07284849 plans to enroll 700 patients, the Phase 1 solid tumor trial NCT05836324 plans 570, and the Phase 2 colorectal cancer trial NCT07823322 plans 40.