A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

JRCT ID: jRCT2041240103

Registered date:09/10/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Pancreatic Ductal Adenocarcinoma
Non-small Cell Lung Cancer
Colorectal Cancer

• Date of first enrollment: 09/10/2024
• Target sample size: 530
• Countries of recruitment: United States,Japan,Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,India,Japan,Israel,Japan,Italy,Japan,Republic of Korea,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Puerto Rico,Japan,Romania,Japan,Slovakia,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

[Interventions]
DRUG: LY3962673
Administered orally.
DRUG: Cetuximab
Administered intravenously.
DRUG: Gemcitabine
Administered intravenously.
DRUG: nab-paclitaxel
Administered intravenously.
DRUG: Oxaliplatin
Administered intravenously.
DRUG: leucovorin
Administered intravenously.
DRUG: Irinotecan
Administered intravenously.
DRUG: 5-fluorouracil
Administered intravenously.
[Study Arms]Experimental: Phase 1a: LY3962673 Dose Escalation
Escalating doses of LY3962673 administered orally.
Interventions:
Drug: LY3962673
Experimental: Phase 1b: LY3962673 Dose Expansion
LY3962673 administered orally either alone or in combination with other chemotherapy agents.
Interventions:
Drug: LY3962673
Drug: Cetuximab
Drug: Gemcitabine
Drug: nab-paclitaxel
Drug: Oxaliplatin
Drug: leucovorin
Drug: Irinotecan
Drug: 5-fluorouracil

Outcome(s)

Primary Outcome

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.
[Time Frame: Baseline through 5 years]

[Phase 1a]
-Number of Participants with DLT
[Time Frame: During the first 28-day cycle of LY3962673 treatment]
-Number of Participants with DLT Equivalent Toxicities
[Time Frame: 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)
[Time Frame: Up to approximately 5 years]
-Best Overall Response (BOR)
BOR per investigator assessed RECIST 1.1
[Time Frame: Up to approximately 5 years]
-Duration of Response (DOR)
DOR per investigator assessed RECIST 1.1
[Time Frame: Up to approximately 5 years]
-Time to Response (TTR)
TTR per investigator assessed RECIST 1.1
[Time Frame: Up to approximately 5 years]
-Disease Control Rate (DCR)
DCR per investigator assessed RECIST 1.1
[Time Frame: Up to approximately 5 years]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Have Histological or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA
- Have an ECOG performance status of <= 1
- Must have received >= 1 prior line of systemic chemotherapy for advanced or metastatic disease
- Participants with asymptomatic or treated CNS disease may be eligible.

Exclude criteria

- Have known active CNS metastases and/or carcinomatous meningitis.
- Have any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1.
- Have significant cardiovascular disease as unstable angina or acute coronary syndrome, history of myocardial infarction, known left ventricular ejection fraction.
- Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
- Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV).
- Have other active malignancy unless in remission with life expectancy greater than (>) 2 years.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT06586515