A Phase 1 interventional study of QTX3034 and Cetuximab in Solid Tumors, sponsored by Quanta Therapeutics. Recruiting at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Quanta Therapeutics · Phase 1, Interventional, and Treatment
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Quanta Therapeutics is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply
QTX3034 will be administered at protocol defined dose based on cohort assignment
Drug: QTX3034
QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Drug: QTX3034 · Combination Product: Cetuximab
QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Drug: QTX3034
QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Drug: QTX3034 · Combination Product: Cetuximab
QTX3034 will be administered at protocol defined dose
Cetuximab will be administered at protocol defined dose.
Number of participants with Dose Limiting Toxicities (DLTs)
DLTs will be defined as the occurrence of any of the toxicities as described in the protocol
Time frame: up to 21 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
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
Time frame: up to 2 years
QTX3034 pharmacokinetic parameters in plasma
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).
Time frame: up to 2 years
Objective response rate (ORR)
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.
Time frame: up to 2 years
Duration of response (DOR)
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.
Time frame: up to 2 years
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Quanta Therapeutics