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ELVN-002 combined with trastuzumab +/- chemotherapy in HER2 + Solid Tumors
EU CTIS ID: 2023-509716-29-00
What this study is testing
Phase 1a: ELVN-002 + Trastuzumab: Evaluate the safety and tolerability of ELVN-002 in combination with trastuzumab in participants with advanced stage HER2 positive solid tumors. Determine the recommended dose(s) (RD) of ELVN-002 in combination with trastuzumab in participants with advanced stage HER2 positive solid tumors Phase 1a: ELVN-002 + Trastuzumab + Chemotherapy: Evaluate the safety and tolerability of treatment of ELVN-002 + trastuzumab + CAPEOX or mFOLFOX6 chemotherapy (capecitabine with oxaliplatin or 5-fluorouracil/leucovorin with oxaliplatin) in participants with advanced stage HER2 positive colorectal cancer. Evaluate the safety and tolerability of treatment of ELVN-002 + trastuzumab + chemotherapy (eribulin, capecitabine or paclitaxel), in participants with advanced stage HER2 positive breast cancer Determine the RD(s) of ELVN-002 when given in combination with trastuzumab and chemotherapy in participants with advanced stage HER2 positive colorectal cancer or breast cancer, or in combination with trastuzumab and paclitaxel in HER2 positive solid tumors Phase 1b: Evaluate the safety and tolerability of treatment with ELVN-002 and trastuzumab in HER2 positive colorectal and breast cancer, and in participants with advanced stage HER2 positive solid tumors. Evaluate the safety and tolerability of treatment with ELVN-002 + trastuzumab + chemotherapy (CAPEOX or mFOLFOX6) in participants with advanced stage HER2 positive colorectal cancer (CRC)
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Participants ≥ 18 years of age at the time of signing the informed consent.
- 2. Pathologically or histologically documented solid tumor.
- 3. Locally advanced or relapsed/refractory disease or unresectable metastatic disease.
- 4. HER2 positive disease (see protocol for futher information)
- 5. Prior Treatment based on Study Part and Histological Tumor Type (see protocol for futher information)
- 6. For Part 3 and Part 4 only (Phase 1b arms): at least 1 measurable lesion based on RECIST v1.1 within 6 weeks prior to first dose of ELVN-002.
You likely can't join if
- 1. Severe cardiac arrhythmias, requiring treatment, symptomatic congestive heart failure (≥ New York Heart Association Functional Classification [NYHAC] II), troponin levels consistent with myocardial infarction within 28 days prior to first dose of ELVN-002, or unstable angina.
- 10. Treatment with other anticancer therapy according to protocol.
- 11. Any brain lesion requiring immediate local therapy.
- 12. Ongoing use of corticosteroids for central nervous system (CNS) symptoms at a dose of > 2 mg daily of dexamethasone (or equivalent) unless have Sponsor approval.
- 13. Leptomeningeal disease.
- 14. Uncontrolled seizures.
See the full eligibility criteria
- 1. Participants ≥ 18 years of age at the time of signing the informed consent.
- 2. Pathologically or histologically documented solid tumor.
- 3. Locally advanced or relapsed/refractory disease or unresectable metastatic disease.
- 4. HER2 positive disease (see protocol for futher information)
- 5. Prior Treatment based on Study Part and Histological Tumor Type (see protocol for futher information)
- 6. For Part 3 and Part 4 only (Phase 1b arms): at least 1 measurable lesion based on RECIST v1.1 within 6 weeks prior to first dose of ELVN-002.
- 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- 8. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) (multigated acquisition [MUGA] allowed if ECHO cannot be performed) within 28 days of the first dose of ELVN-002
- 1. Severe cardiac arrhythmias, requiring treatment, symptomatic congestive heart failure (≥ New York Heart Association Functional Classification [NYHAC] II), troponin levels consistent with myocardial infarction within 28 days prior to first dose of ELVN-002, or unstable angina.
- 10. Treatment with other anticancer therapy according to protocol.
- 11. Any brain lesion requiring immediate local therapy.
- 12. Ongoing use of corticosteroids for central nervous system (CNS) symptoms at a dose of > 2 mg daily of dexamethasone (or equivalent) unless have Sponsor approval.
- 13. Leptomeningeal disease.
- 14. Uncontrolled seizures.
- 15. Ongoing adverse effects from prior treatment > CTCAE Grade 1 except for Grade 2 alopecia
- 16. Corrected QT interval (QTc) of >470 milliseconds (ms) females or >450 ms for males based on average of screening triplicate 12-lead ECG by Fridericia (QTcF)
- 17. Known hypersensitivity to any component of ELVN-002 including inactive ingredients.
- 18. Primary immunodeficiency or known HIV infection. Except patients with undetectable viral load (undetectable viral load must be documented while receiving, for at least 30 days, an anti-retroviral therapy that is not prohibited per Appendix 12).
- 19. Known hypersensitivity to trastuzumab.
- 2. History of another active malignancy within 2 years prior to the first dose except for previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively.
- 20. For the combination with eribulin: known hypersensitivity to eribulin or dehydrated alcohol.
- 21. For the combination cohorts with capecitabine: known hypersensitivity to capecitabine or anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate, talc, titanium dioxide, and synthetic yellow and red iron oxides; known DPD deficiency.
- 22. For the combination cohorts with 5-FU: known hypersensitivity to 5-FU or known DPD deficiency.
- 23. For the combination with paclitaxel: known hypersensitivity to Polyoxyl 35 castor oil, NF, dehydrated alcohol, or Citric Acid.
- 24. For the combination cohorts with oxaliplatin: known hypersensitivity oxaliplatin, any of the excipients or other platinum compounds.
- 3. Serious medical or psychiatric illness likely to interfere with participation in this clinical trial.
- 4. Major surgery within 3 weeks of the first dose of ELVN-002.
- 5. Active or chronic liver disease, including active hepatitis B or C infection.
- 6. Active infection requiring systemic therapy within 14 days before the first dose of ELVN-002.
- 7. History of interstitial lung disease or pulmonary fibrosis.
- 8. Participants for any chemotherapy cohort: ongoing Grade 2 or higher neuropathy of any cause
- 9. Inability to swallow pills or any significant gastrointestinal disease which would preclude adequate oral absorption of medications.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.