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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07713732
- Acronym / sponsor ID
- TLN-499-2601
- Conditions
- Small Cell Lung Cancer ( SCLC ), Neuroendocrine Cancer, Malignant Pleural Mesotheliomas (Mpm), Synovial Sarcomas
- Keywords
- TLN-499, Venetoclax, Relapsed/Refractory Solid Tumors, Small Cell Lung Cancer, Neuroendocrine Cancer, Malignant Pleural Mesothelioma, Synovial Sarcoma, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Treeline Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 29 Aug 2030 (estimated)
- Study completion
- 29 Aug 2030 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation and Part 2 Dose Expansion | Experimental | Drug: TLN-499, Drug: Venetoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLN-499Specified dose on specified days | Drug | Part 1 Dose Escalation and Part 2 Dose Expansion |
| VenetoclaxSpecified dose on specified days | Drug | Part 1 Dose Escalation and Part 2 Dose Expansion |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 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
Time frame: 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)
Time frame: Up to approximately 2 years
ORR assessed according to RECIST v1.1 (or mRECIST for mesothelioma)
7 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of TLN-499
Time frame: Up to approximately 2 years
Time to Peak Drug Concentration (Tmax) of TLN-499
Time frame: Up to approximately 2 years
Minimum Observed Plasma Concentration (Cmin) of TLN-499
Time frame: Up to approximately 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-499
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Padma Yerramilli-Rao, MB BS, PhD study chair
Treeline Biosciences, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Treeline Clinical Operations (857-228-0050, clinicaloperations@treeline.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: First 35 days of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.