Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCA33890 · 4 trials · 5 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.
Major pathologic response (MPR) is defined as proportion of patients with ≤ 10 % residual viable tumor in the resected specimen (primary tumor and cervical lymph nodes) evaluated after three neoadjuvant cycles of INCA33890 or after 2 cycles of pembrolizumab.
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. |
| INCA33890 arm | EXPERIMENTAL | INCA33890 900 mg (9 vials of 100 mg) Q2W for 3 cycles as the investigational treatment of this trial. |
| Pembrolizumab arm | ACTIVE_COMPARATOR | Pembrolizumab 200 mg Q3W for 2 cycles, standard of care treatment for the trial population. |
| 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. |
| Pembrolizumab | DRUG | Pembrolizumab (Keytruda®) is an antineoplastic agent for the treatment of patients with SCCHN |
| 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 small molecule in clinical development by Incyte Corporation for oncology. It is being studied in colorectal cancer, resectable locally advanced head and neck squamous cell carcinoma, and advanced or metastatic solid tumors. It is designed as a bispecific agent directed at TGFβR2 and PD-1, and it is not yet approved for any use.
INCA33890 targets TGFβR2 and PD-1 as a bispecific small molecule, engaging both the TGF-beta receptor 2 pathway and the PD-1 immune checkpoint. This dual targeting is intended to combine checkpoint blockade with TGF-beta pathway inhibition in a single agent, and it is being evaluated in biomarker-selected patient populations.
INCA33890 is being developed by Incyte Corporation, which trades on Nasdaq under the ticker INCY. Incyte is the sponsor of the clinical program, which includes a Phase 3 trial in metastatic microsatellite stable colorectal cancer and earlier-phase studies in head and neck cancer and solid tumors.
INCA33890 is in Phase 3 development. Its most advanced trial is a Phase 3 study in first-line metastatic microsatellite stable colorectal cancer, and additional Phase 2 studies are planned in circulating tumor DNA-positive colorectal cancer and resectable locally advanced head and neck squamous cell carcinoma. INCA33890 remains investigational and is not approved.
INCA33890 is being studied in four registered trials. NCT07284849 is a recruiting Phase 3 trial adding INCA33890 to standard chemotherapy and bevacizumab in first-line metastatic microsatellite stable colorectal cancer. NCT05836324 is a recruiting Phase 1 solid tumor study. NCT07823322 and NCT07876414 are Phase 2 trials not yet recruiting.
No, INCA33890 is not approved by the FDA. It is an investigational agent still in clinical development, with its lead program in Phase 3 testing in metastatic microsatellite stable colorectal cancer. Safety and efficacy have not been established, and access is currently limited to participation in its clinical trials.