Malignant Pleural Mesotheliomas (Mpm), Neuroendocrine Cancer, Small Cell Lung Cancer ( SCLC ), Synovial Sarcomas
Conditions
Keywords
TLN-499, Venetoclax, Relapsed/Refractory Solid Tumors, Small Cell Lung Cancer, Neuroendocrine Cancer, Malignant Pleural Mesothelioma, Synovial Sarcoma, Phase 1
Brief summary
The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of TLN-499 in combination with venetoclax in participants with relapsed/refractory solid tumors.
Interventions
DRUGTLN-499
Specified dose on specified days
DRUGVenetoclax
Specified dose on specified days
Sponsors
Treeline Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥18 years of age 2. Histologically confirmed relapsed/refractory SCLC, neuroendocrine cancer, malignant pleural mesothelioma, or synovial sarcoma 3. Measurable disease per RECIST v1.1 or mRECIST 4. ECOG performance status 0-1 5. Adequate hematologic, hepatic, renal, and coagulation function. 6. Life expectancy ≥12 weeks 7. Signed informed consent
Exclusion criteria
1. Active brain metastases 2. Major surgery or severe trauma within 4 weeks before first dose 3. Significant uncontrolled medical conditions preventing study participation 4. Use of prohibited concomitant medications 5. Previous conditions that would interfere with study assessments or safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose-Limiting Toxicities (DLTs) | First 35 days of treatment | Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-499 |
| Incidence of Adverse Events and Serious Adverse Events | Up to approximately 2 years | Incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and deaths. |
| Overall Response Rate (ORR) | Up to approximately 2 years | ORR assessed according to RECIST v1.1 (or mRECIST for mesothelioma) |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of TLN-499 | Up to approximately 2 years |
| Time to Peak Drug Concentration (Tmax) of TLN-499 | Up to approximately 2 years |
| Minimum Observed Plasma Concentration (Cmin) of TLN-499 | Up to approximately 2 years |
| Area Under the Plasma Concentration-Time Curve (AUC) of TLN-499 | Up to approximately 2 years |
| Duration of Response (DOR) | Up to approximately 2 years |
| Progression-Free Survival (PFS) | Up to approximately 2 years |
| Overall Survival (OS) | Up to approximately 2 years |
Countries
Australia
Contacts
CONTACTTreeline Clinical Operations
STUDY_CHAIRPadma Yerramilli-Rao, MB BS, PhD
Treeline Biosciences, Inc.
Outcome results
None listed