Solid Tumors
Conditions
Brief summary
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Interventions
DRUGQTX3034
QTX3034 will be administered at protocol defined dose
COMBINATION_PRODUCTCetuximab
Cetuximab will be administered at protocol defined dose.
Sponsors
Quanta Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic * Part 1: - Advanced solid tumors with at least 1 prior systemic therapy * Evaluable or Measurable disease per RECIST 1.1. * Parts 2 and 3: Measurable disease per RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Adequate organ function
Exclusion criteria
* Prior treatment with a KRAS inhibitor * Active brain metastases or carcinomatous meningitis * History of other malignancy within 2 years * Significant cardiovascular disease * Disease or disorder that may pose a risk to patient's safety Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Dose Limiting Toxicities (DLTs) | up to 21 days | DLTs will be defined as the occurrence of any of the toxicities as described in the protocol |
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | up to 2 years | Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QTX3034 pharmacokinetic parameters in plasma | up to 2 years | Plasma concentration data for QTX3034 will be used to evaluate PK parameters such as maximum concentration (Cmax), minimum concentration (Cmin), time to attain Cmax (Tmax), area under the concentration-time curve (AUC), elimination half-life (t1⁄2). |
| Objective response rate (ORR) | up to 2 years | The ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1. |
| Duration of response (DOR) | up to 2 years | Duration of response (DoR) is defined as the time between first evidence of objective response and disease progression (as measured by RECIST 1.1) or death, whichever occurs earlier, in subjects who achieve CR or PR. |
Countries
United States
Contacts
CONTACTQuanta Therapeutics Clinical Trials
Outcome results
None listed