Advanced Solid Tumors
Conditions
Brief summary
Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.
Interventions
DRUGQTX3544
QTX3544 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
SEQUENTIAL
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 G12V mutations 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 one prior systemic therapy. * Evaluable and measurable disease per RECIST v1.1. * Part 2 and 3: Measurable disease per RECIST v1.1.
Exclusion criteria
* Active brain metastasis or carcinomatous meningitis * Significant cardiovascular disease * Active infection requiring intravenous (IV) antibiotics * Prior treatment with a KRAS inhibitor Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | up to 2 years | Define 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) of QTX3544 | up to 2 years | Plasma concentration data for QTX3544 will be used to evaluate the area under the concentration-time curve (AUC) of QTX3544. |
| Peak plasma concentration of QTX3544 (Cmax) | up to 2 years | Plasma concentration data for QTX3544 will be used to evaluate peak plasma concentration (Cmax) of QTX3544. |
| 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 | 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
Outcome results
None listed