Brief Summary

The main purpose of this study is to assess safety \& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

630

participants targeted

Target at P75+ for phase_1

Timeline

34mo left

Started Sep 2024

Longer than P75 for phase_1

Geographic Reach

9 countries

52 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.5 years study duration

Study Progress37%

Sep 2024Mar 2029

First Submitted

Initial submission to the registry

September 4, 2024

Completed

8 days until next milestone

Study Start

First participant enrolled

September 12, 2024

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

4.5 years

First QC Date

September 4, 2024

Last Update Submit

April 17, 2026

Conditions

Colorectal Cancer Pancreatic Ductal Adenocarcinoma Non-small Cell Lung Cancer

Keywords

KRAS G12DKRASLY3962673Cetuximabnab-paclitaxelGemcitabineOxaliplatinLeucovorinIrinotecan5-fluorouracil

Outcome Measures

Primary Outcomes (8)

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Baseline through 5 years
Phase 1a: Number of Participants with DLT
During the first 28-day cycle of LY3962673 treatment
Phase 1a: Number of Participants with DLT Equivalent Toxicities
During the first 28-day cycle of LY3962673 treatment
Phase 1b: Overall Response Rate (ORR)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Up to approximately 5 years
Phase 1b: Best Overall Response (BOR)
BOR per investigator assessed RECIST 1.1
Up to approximately 5 years
Phase 1b: Duration of Response (DOR)
DOR per investigator assessed RECIST 1.1
Up to approximately 5 years
Phase 1b: Time to Response (TTR)
TTR per investigator assessed RECIST 1.1
Up to approximately 5 years
Phase 1b: Disease Control Rate (DCR)
DCR per investigator assessed RECIST 1.1
Up to approximately 5 years

Secondary Outcomes (8)

Phase 1a: Overall Response Rate (ORR)
Up to approximately 5 years
Best Overall Response (BOR)
Up to approximately 5 years
Duration of Response (DOR)
Up to approximately 5 years
Time to Response (TTR)
Up to approximately 5 years
Disease Control Rate (DCR)
Up to approximately 5 years
+3 more secondary outcomes

Study Arms (3)

Phase 1a: LY3962673 Dose Escalation

EXPERIMENTAL

Escalating doses of LY3962673 administered orally.

Drug: LY3962673

Phase 1b: LY3962673 Dose Expansion

EXPERIMENTAL

LY3962673 administered orally either alone or in combination with other chemotherapy agents.

Drug: LY3962673Drug: CetuximabDrug: GemcitabineDrug: nab-paclitaxelDrug: OxaliplatinDrug: leucovorinDrug: IrinotecanDrug: 5-fluorouracil

Experimental: Phase 1a: LY3962673 Monotherapy

EXPERIMENTAL

LY3962673 administered orally

Drug: LY3962673

Interventions

LY3962673DRUG

Administered orally.

Experimental: Phase 1a: LY3962673 MonotherapyPhase 1a: LY3962673 Dose EscalationPhase 1b: LY3962673 Dose Expansion

CetuximabDRUG

Administered intravenously.