Advanced Solid TumorsPhase 1/2NCT06993844
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
A Phase 1/2 study testing ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant and ETX-636 dose expansion in combination with fulvestrant in people with Advanced Solid Tumors and Advanced Breast Cancer, run by Ensem Therapeutics at 15 sites in 2 countries.
Trial summary
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Advanced Breast Cancer
- What is being tested?
- ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant and ETX-636 dose expansion in combination with fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 10 Jun 2025to 30 Dec 2027
- 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
- Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.
- Tumor harboring an activating PIK3CA mutation detected in either tumor tissue or ctDNA.
- At least 1 measurable lesion or evaluable disease per RECIST v1.1.
- An ECOG performance status score of 0 or 1.
- Adequate organ function.
- Additional key inclusion criterion for Parts B and C:
- Confirmed metastatic or locally advanced HR+/HER2- breast cancer not amenable to surgical resection with curative intent and must have received at least 1 prior CDK4/6 inhibitor and at least 1 prior anti-estrogen therapy.
Who cannot join
- Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.
- Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
- Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2.
- Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.
- Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.
- Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
United States10 sites, 10 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Susan Gotthardt, 617-975-7452, sgotthar@bidmc.harvard.edu
Gerburg Wulf, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
CT.GOV Contact, 877-338-7425
Sarah Simmons, MD
- Recruiting
NEXT
Fairfax, Virginia, 22031
Maybelle De La Rosa, 703-783-4518, mdelarosa@nextoncology.com
Alex Spira, MD, PhD, FACP
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jordi Rodon Ahnert, MD, PhD, 713-792-5603
Jordi Rodon Ahnert, MD, PhD
- Recruiting
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Hannah Wall, 980-441-1148, hwall@carolinabiooncology.org
Neel Gandhi, MD
- Recruiting
Yale University, Yale Cancer Center
New Haven, Connecticut, 06520
Carl Brown, 203-785-4095, carl.brown@yale.edu
Adriana Kahn, MD
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Angela J Fuller, 949-764-4891, aj.fuller@hoag.org
Monica Mita, MD
- Recruiting
START
San Antonio, Texas, 78229
Isabel Jimenenz, RN, MSN, 210-593-5265, isabel.jimenez@startresearch.com
Amita Patnaik, MD, FRPC
- Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
Phu Lam, 415-818-7994, Phu.Lam@ucsf.edu
Varun Monga, MD
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Kaysey Hermens, 206-667-5715, khermens@fredhutch.org
Jennifer M Specht, MD
China5 sites, 5 recruiting
- Recruiting
Beijing Luhe Hospital,Capital Medical University
Beijing
Dong Yan, 010-60569362, yd15yt88@163.com
Dong Yan, MD
- Recruiting
Fujian Cancer Hospital
Fuzhou
Fan Wu, MD, 0591-62002091, 104247733@qq.com
Fan Wu, MD
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Shusen Wang, MD, 020-87343009, wangshs@sysucc.org.cn
Shusen Wang, MD
- Recruiting
Shandong Cancer Hospital&Institute
Shandong
Huihui Li, MD, 0531-67626929, rxnklihh@163.com
Huihui Li, MD
- Recruiting
Fudan University Shanghai Cancer Hospital
Shanghai
Hongxia Wang, 021-34778299, whx365@126.com
Hongxia Wang, MD
About this study
Official title: A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
Read the detailed description
Brief Summary: This is a Phase 1/2, open-label, multicenter, 3-part study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-636 in participants with advanced solid tumors harboring a PIK3CA mutation.
Part A will evaluate escalating doses of ETX-636 as monotherapy in participants with advanced solid tumors. Part B will evaluate escalating doses of ETX-636 as combination therapy with fixed dose fulvestrant in participants with hormone receptor positive (HR+), HER2 negative (HER2-) locally advanced or metastatic breast cancer. Part C will be a combination therapy expansion in participants with HR+, HER2- locally advanced or metastatic breast cancer.
Each study part will include a 28-day screening period, followed by treatment with ETX-636 monotherapy or combination therapy.
- Conditions
- Advanced Solid Tumors, Advanced Breast Cancer
- Being tested
- ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
- Keywords
- cancer, breast cancer, solid tumors, PIK3CA, PI3Kα inhibitor, Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, HER2-negative breast cancer, HR-positive breast cancer, Gynecologic cancer, Endometrial cancer, Ovarian cancer, Cervical cancer, Head and neck cancer, Head and neck squamous cell carcinoma, Fulvestrant, Antineoplastic Agents, PI3Kα
- Medical subject headings
- Neoplasms, Breast Neoplasms, Hereditary Sensory and Autonomic Neuropathies, Neoplasms by Site, Breast Diseases, Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETX-636 dose escalationDrug
ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet that will be taken once per day in 28-day cycles, to evaluate escalating dose levels.
ETX-636 dose escalation in combination with fulvestrantDrug
Also called Faslodex
ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to evaluate escalating dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections.
ETX-636 dose expansion in combination with fulvestrantDrug
Also called Faslodex
ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to expand selected dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections.
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Escalation Monotherapy (Advanced Solid Tumors with PIK3CA mutation) | Experimental | Part A is a dose escalation monotherapy of ETX-636 in advanced solid tumors with PIK3CA mutation Receives: Drug: ETX-636 dose escalation |
| Part B Dose Escalation Combination Therapy (HR+/HER2- locally advanced or metastatic breast cancer) | Experimental | Part B is a dose escalation combination therapy in HR+/HER2- locally advanced or metastatic breast cancer. The study treatment will be ETX-636, a pan-mutant-selective PI3Kα inhibitor, in combination with fulvestrant (Faslodex) at a fixed dose of 500 mg IM. Receives: Drug: ETX-636 dose escalation in combination with fulvestrant |
| Part C Dose Expansion Combination Therapy (HR+/HER2- locally advanced or metastatic breast cancer) | Experimental | Part B is a dose expansion combination therapy in HR+/HER2- locally advanced or metastatic breast cancer. The study treatment will be ETX-636, a pan-mutant-selective PI3Kα inhibitor, in combination with fulvestrant (Faslodex) at a fixed dose of 500 mg IM. Receives: Drug: ETX-636 dose expansion in combination with fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Safety and Tolerability of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B
Proportion of participants who experience at least 1 Dose Limiting Toxicity (DLT)
Measured: First 28 days of treatment
Evaluate Safety and Tolerability of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B
Incidence of AEs, treatment discontinuations due to AEs, changes from baseline in laboratory assessments, ECGs and vital signs.
Measured: Average of 6 months
Select the Recommended Phase 2 Dose(s) (RP2D) in Part B to be further explored in Part C (combination therapy expansion)
Safety Parameters as described for primary outcomes
Measured: Average of 6 months
Evaluate efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C
ORR and CBR according to RECIST v1.1
Measured: Average of 6 months
Secondary outcomes (14)
Characterize the Cmax (PK) of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B
Maximum observed plasma concentration (Cmax) of ETX-636
Measured: First 2 treatment cycles (each cycle is 28 days)
Characterize the Tmax (PK) of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B
Calculated time to reach maximum observed plasma concentration of ETX-636
Measured: First 2 treatment cycles (each cycle is 28 days)
Characterize the AUC (PK) of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B
Calculated area under the plasma concentration curve (AUC) of ETX-636
Measured: First 2 treatment cycles (each cycle is 28 days)
Measure PD effects of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B and ETX-636 plus fulvestrant at the RP2D(s) in Part C
Change from baseline in ctDNA levels; Change from baseline in PD markers in paired biopsies
Measured: First 3 cycles (each cycle is 28 days)
Changes in fasting blood glucose (All Parts)
Measured by fasting blood glucose
Measured: Average of 6 months
Changes in longitudinal glucose metabolism (All Parts)
Measured by HbA1c
Measured: Average of 6 months
Assess preliminary efficacy of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B
Objective response rate (ORR) and clinical benefit rate (CBR) based on RECIST v1.1
Measured: Average of 6 months
Evaluate measures of efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C
Time to response (TTR) according to RECIST v1.1
Measured: Average of 6 months
Evaluate additional measures of efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C
Duration of response (DoR) according to RECIST v1.1
Measured: Average of 6 months
Evaluate additional measures of efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C
Disease control rate (DCR) according to RECIST v1.1
Measured: Average of 6 months
Evaluate additional measures of efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C
Progression free survival (PFS) according to RECIST v1.1
Measured: Average of 6 months
Evaluate Safety of ETX-636 plus fulvestrant combination therapy at the RP2Ds in Part C
Incidence of adverse events graded according to CTCAE v5.0
Measured: Average of 6 months
Evaluate tolerability of ETX-636 plus fulvestrant combination therapy at the RP2Ds in Part C
Incidence of adverse events graded according to CTCAE v5.0
Measured: Average of 6 months
Characterize the PK of ETX-636 plus fulvestrant using population PK modeling (Part C, to be reported separately)
Plasma concentrations
Measured: First 2 treatment cycles (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start10 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Sequential
- Model description
- Fulvestrant
- Masking
- None (open label)
- Enrolment
- 233 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ensem Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993844
- Sponsor's protocol ID
- ETX636-C-001
- Status last verified
- Oct 2026
- First submitted
- 1 May 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06993844
- Acronym / sponsor ID
- ETX636-C-001
- Conditions
- Advanced Solid Tumors, Advanced Breast Cancer
- Keywords
- cancer, breast cancer, solid tumors, PIK3CA, PI3Kα inhibitor, Breast Neoplasms, Neoplasms by Site, Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 233 participants (estimated)
- Lead sponsor
- Ensem TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 May 2025 (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.
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
Detailed description
Brief Summary: This is a Phase 1/2, open-label, multicenter, 3-part study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-636 in participants with advanced solid tumors harboring a PIK3CA mutation.
Part A will evaluate escalating doses of ETX-636 as monotherapy in participants with advanced solid tumors. Part B will evaluate escalating doses of ETX-636 as combination therapy with fixed dose fulvestrant in participants with hormone receptor positive (HR+), HER2 negative (HER2-) locally advanced or metastatic breast cancer. Part C will be a combination therapy expansion in participants with HR+, HER2- locally advanced or metastatic breast cancer.
Each study part will include a 28-day screening period, followed by treatment with ETX-636 monotherapy or combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Fulvestrant
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Escalation Monotherapy (Advanced Solid Tumors with PIK3CA mutation) | Experimental | Drug: ETX-636 dose escalationPart A is a dose escalation monotherapy of ETX-636 in advanced solid tumors with PIK3CA mutation |
| Part B Dose Escalation Combination Therapy (HR+/HER2- locally advanced or metastatic breast cancer) | Experimental | Drug: ETX-636 dose escalation in combination with fulvestrantPart B is a dose escalation combination therapy in HR+/HER2- locally advanced or metastatic breast cancer. The study treatment will be ETX-636, a pan-mutant-selective PI3Kα inhibitor, in combination with fulvestrant (Faslodex) at a fixed dose of 500 mg IM. |
| Part C Dose Expansion Combination Therapy (HR+/HER2- locally advanced or metastatic breast cancer) | Experimental | Drug: ETX-636 dose expansion in combination with fulvestrantPart B is a dose expansion combination therapy in HR+/HER2- locally advanced or metastatic breast cancer. The study treatment will be ETX-636, a pan-mutant-selective PI3Kα inhibitor, in combination with fulvestrant (Faslodex) at a fixed dose of 500 mg IM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.
- Tumor harboring an activating PIK3CA mutation detected in either tumor tissue or ctDNA.
- At least 1 measurable lesion or evaluable disease per RECIST v1.1.
- An ECOG performance status score of 0 or 1.
- Adequate organ function.
Key exclusion criteria (6 listed)
- Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.
- Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
- Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2.
- Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.
- Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.
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 |
|---|---|---|
| ETX-636 dose escalationETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet that will be taken once per day in 28-day cycles, to evaluate escalating dose levels. | Drug | Part A Dose Escalation Monotherapy (Advanced Solid Tumors with PIK3CA mutation) |
| ETX-636 dose escalation in combination with fulvestrantAlso: FaslodexETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to evaluate escalating dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections. | Drug | Part B Dose Escalation Combination Therapy (HR+/HER2- locally advanced or metastatic breast cancer) |
| ETX-636 dose expansion in combination with fulvestrantAlso: FaslodexETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to expand selected dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections. | Drug | Part C Dose Expansion Combination Therapy (HR+/HER2- locally advanced or metastatic breast cancer) |
Primary outcome
Evaluate Safety and Tolerability of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B
Time frame: First 28 days of treatment
Proportion of participants who experience at least 1 Dose Limiting Toxicity (DLT)
Evaluate Safety and Tolerability of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B
Time frame: Average of 6 months
Incidence of AEs, treatment discontinuations due to AEs, changes from baseline in laboratory assessments, ECGs and vital signs.
Select the Recommended Phase 2 Dose(s) (RP2D) in Part B to be further explored in Part C (combination therapy expansion)
Time frame: Average of 6 months
Safety Parameters as described for primary outcomes
Evaluate efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C
Time frame: Average of 6 months
ORR and CBR according to RECIST v1.1
14 secondary outcomes
Characterize the Cmax (PK) of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B
Time frame: First 2 treatment cycles (each cycle is 28 days)
Characterize the Tmax (PK) of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B
Time frame: First 2 treatment cycles (each cycle is 28 days)
Characterize the AUC (PK) of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B
Time frame: First 2 treatment cycles (each cycle is 28 days)
Measure PD effects of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B and ETX-636 plus fulvestrant at the RP2D(s) in Part C
Time frame: First 3 cycles (each cycle is 28 days)
Changes in fasting blood glucose (All Parts)
Time frame: Average of 6 months
Changes in longitudinal glucose metabolism (All Parts)
Time frame: Average of 6 months
Assess preliminary efficacy of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B
Time frame: Average of 6 months
Evaluate measures of efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C
Time frame: Average of 6 months
Evaluate additional measures of efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C
Time frame: Average of 6 months
Evaluate additional measures of efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C
Time frame: Average of 6 months
Evaluate additional measures of efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C
Time frame: Average of 6 months
Evaluate Safety of ETX-636 plus fulvestrant combination therapy at the RP2Ds in Part C
Time frame: Average of 6 months
Evaluate tolerability of ETX-636 plus fulvestrant combination therapy at the RP2Ds in Part C
Time frame: Average of 6 months
Characterize the PK of ETX-636 plus fulvestrant using population PK modeling (Part C, to be reported separately)
Time frame: First 2 treatment cycles (each cycle is 28 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 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant and ETX-636 dose expansion in combination with fulvestrant in people with Advanced Solid Tumors and Advanced Breast Cancer, run by Ensem Therapeutics at 15 sites in 2 countries.
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 6 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 13 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 15 sites in United States, China. 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?
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 Lori Cykowski (1-617-383-4993, lori.cykowski@Ensemtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Safety and Tolerability of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B (time frame: First 28 days of treatment). The study lists 4 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 13 Oct 2026.