TLN-372 in Advanced KRAS Mutant Solid Tumors
ConditionKRAS Mutant Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTreeline Biosciences, Inc.
About this trial
The primary purpose of this study is to evaluate the safety, pharmacokinetics, and anti-tumor activity of TLN-372 as a single agent and in combination with other anti-tumor agents, in patients with advanced KRAS mutant solid tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have measurable disease at study entry.
Patients must have locally advanced or metastatic KRAS mutant solid tumors.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function.
Disqualifiers
Patients must not have active brain metastases.
Patients must not have current or past history of central nervous system (CNS) involvement.
Patients must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
Patients must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places patients at unacceptable risk of participating in this study.
Trial design
Design model
Sequential
Treatments tested in this trial
TLN-372
DrugSpecified dose on specified days
TLN-372 in combination with cetuximab
DrugSpecified dose on specified days
TLN-372 in combination with pembrolizumab
DrugSpecified dose on specified days
Treatment groups
270 Participants
are divided into 2 treatment groupsGroup A: Single AgentExperimental treatment 1 intervention
Group B: Combination TreatmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372
Time frame
Up to 2 years2
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation.
Time frame
Up to 2 years3
Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1
Time frame
Up to 2 yearsSecondary outcomes
1
Maximum observed plasma concentration (Cmax) of TLN-372
Time frame
Up to 2 years2
Time to peak drug concentration (Tmax) of TLN-372
Time frame
Up to 2 years3
Minimum observed plasma concentration (Cmin) of TLN-372
Time frame
Up to 2 years4
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov