Small Cell Lung Cancer ( SCLC )Phase 1NCT07713732
TLN-499 in Combination With Venetoclax in Patients With Relapsed/Refractory Solid Tumors
A Phase 1 study testing TLN-499 and Venetoclax in people with Small Cell Lung Cancer ( SCLC ) and Neuroendocrine Cancer, run by Treeline Biosciences, Inc. at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer ( SCLC ), Neuroendocrine Cancer, Malignant Pleural Mesotheliomas (Mpm)
- What is being tested?
- TLN-499 and Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesAustralia
- Study dates
- 5 Aug 2026to 29 Aug 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age
- Histologically confirmed relapsed/refractory SCLC, neuroendocrine cancer, malignant pleural mesothelioma, or synovial sarcoma
- Measurable disease per RECIST v1.1 or mRECIST
- ECOG performance status 0-1
- Adequate hematologic, hepatic, renal, and coagulation function.
- Life expectancy ≥12 weeks
- Signed informed consent
Who cannot join
- Active brain metastases
- Major surgery or severe trauma within 4 weeks before first dose
- Significant uncontrolled medical conditions preventing study participation
- Use of prohibited concomitant medications
- Previous conditions that would interfere with study assessments or safety
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Not yet recruiting
COBL Clinical Trials - Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Steven Kao, +61 (2) 8514 0594, Steven.kao@lh.org.au
Steven Kao
- Not yet recruiting
Cabrini Hospital Malvern
Malvern, Victoria, 3144
Surein Arulananda, +61 (3) 9496 3088, surein.arulananda@austin.org.au
Surein Arulananda
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 6009
Timothy Humphries, +61 (08) 6382 5100, thumphries@linear.org.au
Timothy Humphries
About this study
Official title: An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-499 in Combination With Venetoclax in Patients With Relapsed/Refractory Solid Tumors
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.
- Conditions
- Small Cell Lung Cancer ( SCLC ), Neuroendocrine Cancer, Malignant Pleural Mesotheliomas (Mpm), Synovial Sarcomas
- Being tested
- TLN-499, Venetoclax
- Keywords
- TLN-499, Venetoclax, Relapsed/Refractory Solid Tumors, Small Cell Lung Cancer, Neuroendocrine Cancer, Malignant Pleural Mesothelioma, Synovial Sarcoma, Phase 1
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Neuroendocrine, Mesothelioma, Malignant, Sarcoma, Synovial, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLN-499Drug
Specified dose on specified days
VenetoclaxDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation and Part 2 Dose Expansion | Experimental | Not described Receives: Drug: TLN-499; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-499
Measured: First 35 days of treatment
Incidence of Adverse Events and Serious Adverse Events
Incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and deaths.
Measured: Up to approximately 2 years
Overall Response Rate (ORR)
ORR assessed according to RECIST v1.1 (or mRECIST for mesothelioma)
Measured: Up to approximately 2 years
Secondary outcomes (7)
Maximum Observed Plasma Concentration (Cmax) of TLN-499
Measured: Up to approximately 2 years
Time to Peak Drug Concentration (Tmax) of TLN-499
Measured: Up to approximately 2 years
Minimum Observed Plasma Concentration (Cmin) of TLN-499
Measured: Up to approximately 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-499
Measured: Up to approximately 2 years
Duration of Response (DOR)
Measured: Up to approximately 2 years
Progression-Free Survival (PFS)
Measured: Up to approximately 2 years
Overall Survival (OS)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start5 Aug 2026
- Primary completion29 Aug 2030 (estimated)
- Study completion29 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer ( SCLC )Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Treeline Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Padma Yerramilli-Rao, MB BS, PhD, Study chair, Treeline Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713732
- Sponsor's protocol ID
- TLN-499-2601
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No