PDACPhase 1/2NCT07897734
TNG462-C103: Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Vopimetostat in Combination With ERAS-0015 in PDAC and NSCLC Patients
A Phase 1/2 study testing vopimetostat and ERAS-0015 in people with PDAC and PDAC - Pancreatic Ductal Adenocarcinoma, run by Tango Therapeutics, Inc..
Trial summary
TNG462-C103 is a Phase 1/2 study to investigate the safety and antitumor activity of vopimetostat (TNG462) combined with ERAS-0015 in patients with MTAP-null pancreatic or MTAP-null non-small cell lung cancer with RAS mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC
- What is being tested?
- vopimetostat and ERAS-0015
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to May 2032
- Phase
- Phase 1/2
- 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
- Is ≥18 years of age at the time of signature of the main study ICF.
- Has an ECOG PS of 0 or 1.
- Has loss of the MTAP gene, documented by a validated assay
- Has one of the following disease characteristics:
- 1L or 2L metastatic PDAC
- Locally advanced, recurrent or metastatic NSCLC (no more than 2 prior lines of therapy) with documented KRAS mutation at G12X or G13X locally obtained via an analytically validated assay (Dose expansion only).
- Has evidence of measurable disease based on RECIST v1.1.
- Adequate organ function
Who cannot join
- Has received prior treatment with a PRMT5 inhibitor, MAT2A inhibitor or RAS inhibitor.
- Has an active infection requiring systemic therapy.
- Any condition that may impact the ability to take or absorb study drugs
- Has known or suspected active or untreated CNS metastases associated with progressive neurological symptoms
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Vopimetostat in Combination With ERAS-0015 (RAS Inhibitor) in Patients With MTAP-null Pancreatic Cancer and MTAP-null Non-Small Cell Lung Cancer With RAS Mutation
TNG462-C103 is a Phase 1/2 study to investigate the safety and antitumor activity of vopimetostat (TNG462) combined with ERAS-0015 in patients with MTAP-null pancreatic or MTAP-null non-small cell lung cancer with RAS mutation.
Read the detailed description
TNG462-C103 is a Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Vopimetostat (PRMT5 inhibitor) in Combination with ERAS-0015 (pan-RAS molecular glue) in Patients with MTAP-null Pancreatic Cancer and MTAP-null Non-Small Cell Lung Cancer with RAS Mutation.
The study will be conducted in patients with MTAP- null pancreatic adenocarcinoma (PDAC) or locally advanced or metastatic MTAP loss non-small cell lung cancer (NSCLC) with RAS mutation in 2 parts: Phase 1 (dose escalation) and Phase 2 (dose expansion).
Individual arms in dose expansion may open once the MTD and/or RD(s) has been determined for the corresponding combination in dose escalation.
- Conditions
- PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC, RAS Mutation, MTAP Deletion, Lung Cancer
- Being tested
- vopimetostat, ERAS-0015
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vopimetostatDrug
MTA-cooperative PRMT5 inhibitor
ERAS-0015Drug
Pan-RAS molecular glue
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation PDAC | Experimental | Escalating doses of vopimetostat in combination with ERAS-0015 Receives: Drug: vopimetostat; Drug: ERAS-0015 |
| Dose expansion 1L PDAC | Experimental | Expansion arm at the RD(s) of vopimetostat in combination with ERAS-0015 Receives: Drug: vopimetostat; Drug: ERAS-0015 |
| Dose Expansion 2L PDAC | Experimental | Expansion arm at the RD(s) of vopimetostat in combination with ERAS-0015 Receives: Drug: vopimetostat; Drug: ERAS-0015 |
| Dose Expansion 2L or 3L NSCLC | Experimental | Expansion arm at the RD(s) of vopimetostat in combination with ERAS-0015 Receives: Drug: vopimetostat; Drug: ERAS-0015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Maximum Tolerated Dose
To determine the MTD and RD(s) of vopimetostat in combination with ERAS-0015
Measured: 21 days
Phase 2 Combination Anti-neoplastic Activity
To assess antitumor activity- ORR of vopimetostat in combination with ERAS-0015
Measured: 12 weeks
Secondary outcomes (3)
Phase 1 and 2 Combination Anti-neoplastic Activity
To assess antitumor activity of vopimetostat in combination with ERAS-0015
Measured: 12 weeks
Phase 1 and 2 PK Profile of vopimetostat and ERAS-0015 in Combination
To characterize the PK profile of vopimetostat and ERAS-0015 when taken in combination
Measured: 21 days
Phase 1 and 2 Adverse Event Profile
To determine the safety and tolerability of vopimetostat in combination with ERAS-0015
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2031 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDACStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation of vopimetostat + ERAS-0015 in MTAP-null PDAC followed by expansion in MTAP-null PDAC and MTAP-null NSCLC with RAS Mutation
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tango Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Erasca, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897734
- Sponsor's protocol ID
- TNG462-C103
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Vopimetostat in Combination With ERAS-0015 (RAS Inhibitor) in Patients With MTAP-null Pancreatic Cancer and MTAP-null Non-Small Cell Lung Cancer With RAS Mutation
- ClinicalTrials.gov ID
- NCT07897734
- Acronym / sponsor ID
- TNG462-C103
- Conditions
- PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC, RAS Mutation, MTAP Deletion, Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Tango Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Erasca, Inc.
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 27 Oct 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.
TNG462-C103 is a Phase 1/2 study to investigate the safety and antitumor activity of vopimetostat (TNG462) combined with ERAS-0015 in patients with MTAP-null pancreatic or MTAP-null non-small cell lung cancer with RAS mutation.
Detailed description
TNG462-C103 is a Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Vopimetostat (PRMT5 inhibitor) in Combination with ERAS-0015 (pan-RAS molecular glue) in Patients with MTAP-null Pancreatic Cancer and MTAP-null Non-Small Cell Lung Cancer with RAS Mutation.
The study will be conducted in patients with MTAP- null pancreatic adenocarcinoma (PDAC) or locally advanced or metastatic MTAP loss non-small cell lung cancer (NSCLC) with RAS mutation in 2 parts: Phase 1 (dose escalation) and Phase 2 (dose expansion).
Individual arms in dose expansion may open once the MTD and/or RD(s) has been determined for the corresponding combination in dose escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Dose escalation of vopimetostat + ERAS-0015 in MTAP-null PDAC followed by expansion in MTAP-null PDAC and MTAP-null NSCLC with RAS Mutation
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation PDAC | Experimental | Drug: vopimetostat, Drug: ERAS-0015Escalating doses of vopimetostat in combination with ERAS-0015 |
| Dose expansion 1L PDAC | Experimental | Drug: vopimetostat, Drug: ERAS-0015Expansion arm at the RD(s) of vopimetostat in combination with ERAS-0015 |
| Dose Expansion 2L PDAC | Experimental | Drug: vopimetostat, Drug: ERAS-0015Expansion arm at the RD(s) of vopimetostat in combination with ERAS-0015 |
| Dose Expansion 2L or 3L NSCLC | Experimental | Drug: vopimetostat, Drug: ERAS-0015Expansion arm at the RD(s) of vopimetostat in combination with ERAS-0015 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is ≥18 years of age at the time of signature of the main study ICF.
- Has an ECOG PS of 0 or 1.
- Has loss of the MTAP gene, documented by a validated assay
- Has one of the following disease characteristics:
- Has evidence of measurable disease based on RECIST v1.1.
Key exclusion criteria (4 listed)
- Has received prior treatment with a PRMT5 inhibitor, MAT2A inhibitor or RAS inhibitor.
- Has an active infection requiring systemic therapy.
- Any condition that may impact the ability to take or absorb study drugs
- Has known or suspected active or untreated CNS metastases associated with progressive neurological symptoms
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 |
|---|---|---|
| vopimetostatMTA-cooperative PRMT5 inhibitor | Drug | Dose Escalation PDAC, Dose Expansion 2L PDAC, Dose Expansion 2L or 3L NSCLC, Dose expansion 1L PDAC |
| ERAS-0015Pan-RAS molecular glue | Drug | Dose Escalation PDAC, Dose Expansion 2L PDAC, Dose Expansion 2L or 3L NSCLC, Dose expansion 1L PDAC |
Primary outcome
Phase 1 Maximum Tolerated Dose
Time frame: 21 days
To determine the MTD and RD(s) of vopimetostat in combination with ERAS-0015
Phase 2 Combination Anti-neoplastic Activity
Time frame: 12 weeks
To assess antitumor activity- ORR of vopimetostat in combination with ERAS-0015
3 secondary outcomes
Phase 1 and 2 Combination Anti-neoplastic Activity
Time frame: 12 weeks
Phase 1 and 2 PK Profile of vopimetostat and ERAS-0015 in Combination
Time frame: 21 days
Phase 1 and 2 Adverse Event Profile
Time frame: 21 days
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 27 Oct 2026.
Related trials for PDAC
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
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RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS
RecruitingPhase 3
Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing vopimetostat and ERAS-0015 in people with PDAC and PDAC - Pancreatic Ductal Adenocarcinoma, run by Tango Therapeutics, Inc..
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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Maxim Pimkin, MD, PhD (857-320-4899, clinicaltrials@tangotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Maximum Tolerated Dose (time frame: 21 days). The study lists 2 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 27 Oct 2026.