Advanced or Metastatic Solid TumorsPhase 1/2HERKULES-1NCT04866134
A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing ERAS-007 and ERAS-601 in people with Advanced or Metastatic Solid Tumors, run by Erasca, Inc. at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- ERAS-007 and ERAS-601
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 May 2021to 1 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Mary Crowley Cancer Research
Dallas, Texas, 75251
Sarah Cannon Research Institute (HealthONE)
Denver, Colorado, 80218
Sarah Cannon Research Institute (Tennessee Oncology)
Nashville, Tennessee, 37203
NEXT Oncology
San Antonio, Texas, 78229
Sarah Cannon Research Institute (Florida Cancer Specialists)
Sarasota, Florida, 34232
About this study
Official title: 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)
- 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
Read the detailed description
This is a Phase 1b/2, open-label, multicenter clinical study of ERAS-007 monotherapy (QW or BID-QW) administered either QW or BID-QWand ERAS-007 (BID-QW) in combination with ERAS-601 (BID 3/1). The monotherapy RD on a weekly schedule has been determined to be 250 mg QW in a previous study. The dose escalation phases of this study will test ERAS-007 monotherapy administered BID-QW as a monotherapy or in combination with ERAS-601 in participants with any solid tumor. The monotherapy RD on a weekly schedule has been determined to be 250 mg QW in a previous study. In parallel, the dose expansion phase of this study will test ERAS-007 monotherapy administered at the RD of 250 mg QW in participants with advanced or metastatic solid tumors harboring specific molecular alterations. Once sufficient safety and PK data are available from the BID-QW dose escalation phase, the Sponsor will then determine the optimal dose and schedule of ERAS-007 administered as a monotherapy.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- ERAS-007, ERAS-601
- Keywords
- ERK, solid tumor, advanced solid tumor, metastatic solid tumor, neoplasms, solid malignancies, MAPK, SHP2
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS-007Drug
ERAS-007 will be administered orally as specified in Arm description.
ERAS-601Drug
ERAS-601 will be administered orally as specified in Arm description.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation (Part A): ERAS-007 Monotherapy, BID-QW dosing | Experimental | 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. Receives: Drug: ERAS-007 |
| Dose Expansion (Part B): ERAS-007 Monotherapy, QW dosing | Experimental | ERAS-007 monotherapy will be administered at 250 mg QW to participants with advanced or metastatic solid tumors that harbor specific molecular alterations. Receives: Drug: ERAS-007 |
| Dose Expansion (Part C): ERAS-007 Monotherapy, BID-QW dosing (if necessary) | Experimental | Depending on data generated from Part A, ERAS-007 monotherapy may be administered at the BID-QW RD to participants with advanced or metastatic solid tumors that harbor specific molecular alterations. Receives: Drug: ERAS-007 |
| Dose Escalation (Part D): ERAS-007 BID-QW dosing in combination with ERAS-601 | Experimental | Experimental: Dose Escalation (Part D): ERAS-007 BID-QW dosing in combination with ERAS-601 ERAS-007 will be administered BID-QW in combination with ERAS-601 administered BID 3/1 to study participants with advanced or metastatic solid tumors that harbor specific molecular targets in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent. Receives: Drug: ERAS-007; Drug: ERAS-601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and tolerability of escalating doses of ERAS-007 BID-QW
Based on adverse events observed
Measured: Assessed up to 24 months from time of first dose
Dose Limiting Toxicities (DLT)
Based on adverse events observed
Measured: Study Day 1 up to Day 29
Maximum tolerated dose (MTD)
Based on adverse events observed
Measured: Study Day 1 up to Day 29
Recommended dose (RD)
Based on adverse events observed
Measured: Study Day 1 up to Day 29
Adverse Events
Incidence and severity of treatment-emergent AEs and serious AEs
Measured: Assessed up to 24 months from time of first dose
Plasma concentration (Cmax)
Maximum plasma concentration of ERAS-007
Measured: Study Day 1 up to Day 29
Time to achieve Cmax (Tmax)
Time to achieve maximum plasma concentration of ERAS-007 and ERAS-601
Measured: Study Day 1 up to Day 29
Area under the curve
Area under the plasma concentration-time curve of ERAS-007 and ERAS-601
Measured: Study Day 1 up to Day 29
Half-life
Half-life of ERAS-007 and ERAS-601
Measured: Study Day 1 up to Day 29
Secondary outcomes (3)
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Assessed up to 24 months from time of first dose
Time to Response (TTR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Assessed up to 24 months from time of first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start7 May 2021
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasca, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Lin, M.D., Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866134
- Sponsor's protocol ID
- ERAS-007-01
- Acronym
- HERKULES-1
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2021
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04866134
- Acronym / sponsor ID
- HERKULES-1 / ERAS-007-01
- Conditions
- Advanced or Metastatic Solid Tumors
- Keywords
- ERK, solid tumor, advanced solid tumor, metastatic solid tumor, neoplasms, solid malignancies, MAPK, SHP2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Erasca, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 May 2021 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 29 Apr 2021 (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.
- 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
Detailed description
This is a Phase 1b/2, open-label, multicenter clinical study of ERAS-007 monotherapy (QW or BID-QW) administered either QW or BID-QWand ERAS-007 (BID-QW) in combination with ERAS-601 (BID 3/1). The monotherapy RD on a weekly schedule has been determined to be 250 mg QW in a previous study. The dose escalation phases of this study will test ERAS-007 monotherapy administered BID-QW as a monotherapy or in combination with ERAS-601 in participants with any solid tumor. The monotherapy RD on a weekly schedule has been determined to be 250 mg QW in a previous study. In parallel, the dose expansion phase of this study will test ERAS-007 monotherapy administered at the RD of 250 mg QW in participants with advanced or metastatic solid tumors harboring specific molecular alterations. Once sufficient safety and PK data are available from the BID-QW dose escalation phase, the Sponsor will then determine the optimal dose and schedule of ERAS-007 administered as a monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation (Part A): ERAS-007 Monotherapy, BID-QW dosing | Experimental | Drug: ERAS-007ERAS-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. |
| Dose Expansion (Part B): ERAS-007 Monotherapy, QW dosing | Experimental | Drug: ERAS-007ERAS-007 monotherapy will be administered at 250 mg QW to participants with advanced or metastatic solid tumors that harbor specific molecular alterations. |
| Dose Expansion (Part C): ERAS-007 Monotherapy, BID-QW dosing (if necessary) | Experimental | Drug: ERAS-007Depending on data generated from Part A, ERAS-007 monotherapy may be administered at the BID-QW RD to participants with advanced or metastatic solid tumors that harbor specific molecular alterations. |
| Dose Escalation (Part D): ERAS-007 BID-QW dosing in combination with ERAS-601 | Experimental | Drug: ERAS-007, Drug: ERAS-601Experimental: Dose Escalation (Part D): ERAS-007 BID-QW dosing in combination with ERAS-601 ERAS-007 will be administered BID-QW in combination with ERAS-601 administered BID 3/1 to study participants with advanced or metastatic solid tumors that harbor specific molecular targets in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| ERAS-007ERAS-007 will be administered orally as specified in Arm description. | Drug | Dose Escalation (Part A): ERAS-007 Monotherapy, BID-QW dosing, Dose Escalation (Part D): ERAS-007 BID-QW dosing in combination with ERAS-601, Dose Expansion (Part B): ERAS-007 Monotherapy, QW dosing, Dose Expansion (Part C): ERAS-007 Monotherapy, BID-QW dosing (if necessary) |
| ERAS-601ERAS-601 will be administered orally as specified in Arm description. | Drug | Dose Escalation (Part D): ERAS-007 BID-QW dosing in combination with ERAS-601 |
Primary outcome
Evaluate safety and tolerability of escalating doses of ERAS-007 BID-QW
Time frame: Assessed up to 24 months from time of first dose
Based on adverse events observed
Dose Limiting Toxicities (DLT)
Time frame: Study Day 1 up to Day 29
Based on adverse events observed
Maximum tolerated dose (MTD)
Time frame: Study Day 1 up to Day 29
Based on adverse events observed
Recommended dose (RD)
Time frame: Study Day 1 up to Day 29
Based on adverse events observed
Adverse Events
Time frame: Assessed up to 24 months from time of first dose
Incidence and severity of treatment-emergent AEs and serious AEs
Plasma concentration (Cmax)
Time frame: Study Day 1 up to Day 29
Maximum plasma concentration of ERAS-007
Time to achieve Cmax (Tmax)
Time frame: Study Day 1 up to Day 29
Time to achieve maximum plasma concentration of ERAS-007 and ERAS-601
Area under the curve
Time frame: Study Day 1 up to Day 29
Area under the plasma concentration-time curve of ERAS-007 and ERAS-601
Half-life
Time frame: Study Day 1 up to Day 29
Half-life of ERAS-007 and ERAS-601
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Time frame: Assessed up to 24 months from time of first dose
Time to Response (TTR)
Time frame: Assessed up to 24 months from time of first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced or Metastatic Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 1
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
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. This study is not recruiting at the moment.
Wei Lin, M.D. study director
Chief Medical Officer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ERAS-007 and ERAS-601 in people with Advanced or Metastatic Solid Tumors, run by Erasca, Inc. at 5 sites in United States.
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 10 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: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety and tolerability of escalating doses of ERAS-007 BID-QW (time frame: Assessed up to 24 months from time of first dose). The study lists 9 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 16 Sep 2026.