Clinical trial · Interventional
A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
A Phase 1b/2, Open-label, Multi-center Study of ERAS-007 (ERK Inhibitor) Administered as Monotherapy or in Combination With ERAS-601 (SHP2 Inhibitor) in Patients With Advanced or Metastatic Solid Tumors (HERKULES-1)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
* To evaluate the safety and tolerability of ERAS-007 monotherapy administered once weekly (QW) and twice daily-once weekly (BID-QW). * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 monotherapy administered BID-QW. * To characterize the pharmacokinetic (PK) profile of ERAS-007 monotherapy. * To determine the optimal dose and schedule of ERAS-007 monotherapy. * To evaluate antitumor activity of ERAS-007 in various solid tumors. * To evaluate the safety and tolerability of ERAS-007 (BID-QW) and ERAS-601 (twice daily for three weeks on and 1 week off (BID 3/1)) when administered in combination. * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 administered in combination with ERAS-601. * To characterize the pharmacokinetic (PK) profile of ERAS-007 and ERAS-601 when administered in combination. * To evaluate antitumor activity of ERAS-007 and ERAS-601 when administered in combination in various solid tumors * To evaluate antitumor activity of ERAS-007 and ERAS-601 when administered in combination in various solid tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERAS-007 | Drug | — | UNRESOLVED |
| ERAS-601 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose Escalation (Part A): ERAS-007 Monotherapy, BID-QW dosing
- description
- ERAS-007 monotherapy will be administered BID-QW in sequential ascending doses to participants with advanced or metastatic solid tumors until unacceptable toxicity, disease progression, or withdrawal of consent.
- interventionNames
- Drug: ERAS-007
- type
- EXPERIMENTAL
- label
- Dose Expansion (Part B): ERAS-007 Monotherapy, QW dosing
- description
- ERAS-007 monotherapy will be administered at 250 mg QW to participants with advanced or metastatic solid tumors that harbor specific molecular alterations.
- interventionNames
- Drug: ERAS-007
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Willing and able to give written informed consent. * Have histologically or cytologically confirmed advanced or metastatic solid tumor with a relevant molecular alteration (as applicable). * There is no available standard systemic therapy available for the patient's tumor histology and/or molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy. * Recovered from all toxicities associated with prior treatment to acceptable baseline status. * Have ECOG performance status of 0 or 1 with an anticipated life expectancy of \> 12 weeks. * Willing to comply with all protocol-required visits, assessments, and procedures. * Able to swallow oral medication. Exclusion Criteria: * Currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-007. * Received previous treatment with an ERK inhibitor. * For participants being considered for ERAS-007 + ERAS-601 (Part D): prior treatment with SHP2 inhibitor. * For participants being considered for ERAS-007 + ERAS-601 (Part D): documented PTPN11 mutations * Received prior antineoplastic therapy within \< 21 days or 5 half-lives, whichever is shorter. * Received prior palliative radiation within 7 days of first dose of ERAS 007 or ERAS-601, * Received previous treatment with a MAPK inhibitor that resulted in discontinuation due to unacceptable toxicity. * Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption. * Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs. * Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.
References
Publications (0)
Data not yet available