INCB161734 for Solid Tumors

Recruiting at 42 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: KRAS G12D inhibitors

Disqualifiers: Invasive malignancy, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years and 90 days

710 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new drug, INCB161734, for individuals with advanced or metastatic solid tumors that have a specific KRAS G12D mutation. The study will evaluate how the drug works alone and in combination with other cancer treatments. It suits those whose cancer has worsened after standard treatments or who can no longer undergo those treatments. Participants should have a KRAS G12D mutation and solid tumors that have spread or are inoperable. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that INCB161734 has a good safety record in early studies. Patients who used INCB161734 alone generally tolerated it well, with most not experiencing serious side effects.

When combined with other cancer treatments, INCB161734 still appears safe. Researchers continue to collect information, but early results suggest that combining INCB161734 with other treatments does not cause unexpected or serious side effects.

These findings come from early trials focused on safety and tolerability. While the results are encouraging, more research is needed to fully understand the safety of INCB161734. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for solid tumors involve chemotherapy, radiation, or surgery. However, INCB161734 is unique because it targets the tumor's specific molecular pathways, potentially offering a more precise attack on cancer cells with fewer side effects. Researchers are excited about INCB161734 because it might work effectively as both a monotherapy and in combination with other drugs, which could enhance its reach and effectiveness. Additionally, this treatment explores how food intake affects drug absorption, which could lead to more personalized treatment plans and improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective for solid tumors?

Research shows that INCB161734 is under investigation as a potential treatment for solid tumors in this trial. Participants may receive INCB161734 either as a monotherapy or combined with other treatments, depending on their assigned study arm. Although detailed results are not yet available, early data from patient studies suggest that the drug may stabilize the disease in some cases, preventing tumor growth or spread during treatment. The drug targets specific parts of cancer cells, potentially slowing their growth. Its effectiveness remains under study, but initial findings offer hope that it could become a valuable component of cancer treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors that have a specific mutation called KRAS G12D. Participants must have tried standard treatments without success, be intolerant to them, or have no other treatment options available to improve their condition.

Inclusion Criteria

I have been diagnosed with colorectal cancer.

My condition worsened after standard treatment, or I can't tolerate/have no standard treatment options.

My condition is an advanced solid tumor not classified in groups 1, 2, or 3.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB161734 as a single agent or in combination with other anticancer therapies

Up to 2 years and 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Cetuximab
• INCB161734
• Retifanlimab

Trial Overview The study tests the safety and effects of INCB161734 alone or combined with anticancer therapies like Cetuximab and Retifanlimab. It aims to find out how well these treatments work on various solid tumors with the KRAS G12D mutation.

How Is the Trial Designed?

Group I: Part 2b: Dose Expansion combination Experimental Treatment 8 Interventions

INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.

Group II: Part 2a: Dose Escalation combination Experimental Treatment 8 Interventions

INCB161734 in combination at the protocol-defined dose strength based on cohort assignment.

Group III: Part 1d: Food-Effect Experimental Treatment 1 Intervention

Evaluate food effect on drug exposure as defined in the protocol.

Group IV: Part 1c: Pharmacodynamic cohort Experimental Treatment 1 Intervention

INCB161734 at the protocol-defined dose strength based on cohort assignment.

Group V: Part 1b: Dose Expansion monotherapy Experimental Treatment 1 Intervention

INCB161734 at the protocol-defined dose strength based on cohort assignment.

Group VI: Part 1a: Dose Escalation monotherapy Experimental Treatment 1 Intervention

INCB161734 at the protocol-defined dose strength based on cohort assignment.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

1. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-phase-1-results-its-tgfbr2pd-1-bispecific

Incyte Announces Phase 1 Results for its TGFβR2×PD-1 ... Evaluation of the data for INCB161734 in patients with PDAC is ongoing with results expected in 2026. Based on the findings, the company ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06179160

NCT06179160 | A Study to Evaluate INCB161734 in ... This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

3. incytemi.com incytemi.com/document/Poster/ESMO%202025%20-%20INCB161734%20KRASG12D%20in%20Solid%20Tumors%20(oral%20presentation).pdf

Preliminary Phase 1 Results of INCB161734, a Novel Oral ... All PK data were from part 1b (monotherapy dose expansion). Error bars ... RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.

4. incyteclinicaltrials.com incyteclinicaltrials.com/solid-tumors

living with cancer? This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies. ... The ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20571135

INCB161734 for Advanced or Metastatic Solid Tumors With ... The purpose of this study is to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

6. clinicaloptions.com clinicaloptions.com/activities/oncology/incb161734/122978/content

INCB161734 Phase I Trial of the KRAS G12D Inhibitor INCB161734 in Previously Treated KRAS G12D–Mutant Advanced Solid Tumors. Released: November 03, 2025.