Advanced Solid TumorPhase 1/2NCT06525298
EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
A Phase 1/2 study testing EIS-12656, Olaparib and Trastuzumab deruxtecan in people with Advanced Solid Tumor and Homologous Recombination Deficiency, run by Eisbach Bio GmbH at 1 site in United States.
Trial summary
This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Homologous Recombination Deficiency, HRR Deficiency
- What is being tested?
- EIS-12656, Olaparib and Trastuzumab deruxtecan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2024to 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
- Recurrent locally advanced or metastatic solid tumors
- Homologous recombination deficient mutations
- Progressed on at least on prior line of treatment or intolerant to additional effective standard therapy
- Measurable disease (RECIST 1.1 Criteria)
- Adequate organ and bone marrow function
- ECOG Performance Status 0 or 1
- Life expectancy > 3 months
Who cannot join
- History or evidence of any clinically relevant gastrointestinal disease
- Radiation therapy within ≤2 weeks
- Significant cardiovascular disease
- Uncontrolled, active, symptomatic brain metastases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Timothy Yap, 713-563-1784, TYap@mdanderson.org
About this study
Official title: A Phase 1/2, Open Label Trial to Investigate the Safety, Tolerability, and Preliminary Efficacy of EIS-12656 as Single Agent and in Combination With a Poly-ADP Ribose Polymerase (PARP) Inhibitor or Trastuzumab Deruxtecan (T-DXd), an Antibody Drug Conjugate (ADC), in Participants With Specified Solid Tumors
This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).
Read the detailed description
The trial is a Phase 1/2, open label, uncontrolled trial to investigate the safety and preliminary efficacy of EIS-12656 alone or in combination with a PARPi or T-DXd in patients with specified advanced or metastatic solid tumors with homologous recombination deficient (HRD) mutations.
In the Phase 1 dose escalation phase participants will receive ascending doses of EIS-12656 to evaluate the safety and tolerability and to determine an effective and safe dose for the Phase 2 part.
In the Phase 2 dose expansion phase participants will either receive EIS-12656 monotherapy at the recommended Phase 2 dose (RP2D) (Module 1) or EIS-12656 in combination with a PARPi or T-DXd (Modules 2 and 3). The objective is to evaluate the safety and tolerability and anti-tumor activity of EIS-12656 alone or in combination.
- Being tested
- EIS-12656, Olaparib, Trastuzumab deruxtecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIS-12656Drug
EIS-12656 tablets given daily
OlaparibDrug
as per USPI/SmPC
Trastuzumab deruxtecanDrug
Also called Enhertu
as per USPI/SmPC
| Study group | Role | What they receive |
|---|---|---|
| EIS-12656 Dose Escalation | Experimental | Not described Receives: Drug: EIS-12656 |
| Dose Expansion Module 1 (EIS-12656 Monotherapy) | Experimental | Not described Receives: Drug: EIS-12656 |
| Dose Expansion Module 2 (EIS-12656 + Olaparib) | Experimental | EIS-12656 will be given in combination with Olaparib Receives: Drug: EIS-12656; Drug: Olaparib |
| Dose Expansion Module 3 (EIS-12656 + T-DXd) | Experimental | EIS-12656 will be given in combination with Trastuzumab deruxtecan Receives: Drug: EIS-12656; Drug: Trastuzumab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Number and percentage of participants with adverse events, serious adverse events, adverse events of special interest including changes in safety lab parameters, physical examinations, vital signs, and electrocardiogram (ECG)
Measured: From screening until end of treatment follow-up (45 days after last dose) (up to 7 months)
Number and percentage of participants experiencing a dose limiting toxicity (DLT) (dose escalation part only)
A DLT is defined as an EIS-12656 related adverse event during the first treatment cycle that meets the criteria outlined in the study protocol
Measured: Within 21 days of first dose
Secondary outcomes (6)
Maximum plasma concentration of EIS-12656 (Cmax)
The concentration of EIS-12656 in plasma will be determined (Cmax will be derived)
Measured: At pre-defined intervals from pre-dose Day 1 to Day 29
Area under the curve (AUC0-24)
The AUC0-24 reflects the actual body exposure to drug over the last 24h dosing interval
Measured: At pre-defined intervals from pre-dose Day 1 to Day 29
Time to maximum concentration (Tmax)
The concentration of EIS-12656 in plasma will be determined (Tmax will be derived)
Measured: At pre-defined intervals from pre-dose Day 1 to Day 29
Overall Response Rate
Overall response rate defined as percentage of participants with the best overall response of confirmed CR or confirmed PR according to RECIST v1.1
Measured: From screening to disease progression (approximately 1 year)
Duration of Response
Time from first response to progression or death, as defined by RECIST 1.1
Measured: From screening to disease progression or death (approximately 1 year)
Progression Free Survival
Time from first dose of EIS-12656 to progression or death, as defined by RECIST 1.1
Measured: From screening to disease progression or death (approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start9 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionDec 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 TumorStudies 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
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisbach Bio GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Yap, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525298
- Sponsor's protocol ID
- EIS-12656C01
- Status last verified
- Sep 2024
- First submitted
- 17 Jul 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open Label Trial to Investigate the Safety, Tolerability, and Preliminary Efficacy of EIS-12656 as Single Agent and in Combination With a Poly-ADP Ribose Polymerase (PARP) Inhibitor or Trastuzumab Deruxtecan (T-DXd), an Antibody Drug Conjugate (ADC), in Participants With Specified Solid Tumors
- ClinicalTrials.gov ID
- NCT06525298
- Acronym / sponsor ID
- EIS-12656C01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Eisbach Bio GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Jul 2024 (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.
This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).
Detailed description
The trial is a Phase 1/2, open label, uncontrolled trial to investigate the safety and preliminary efficacy of EIS-12656 alone or in combination with a PARPi or T-DXd in patients with specified advanced or metastatic solid tumors with homologous recombination deficient (HRD) mutations.
In the Phase 1 dose escalation phase participants will receive ascending doses of EIS-12656 to evaluate the safety and tolerability and to determine an effective and safe dose for the Phase 2 part.
In the Phase 2 dose expansion phase participants will either receive EIS-12656 monotherapy at the recommended Phase 2 dose (RP2D) (Module 1) or EIS-12656 in combination with a PARPi or T-DXd (Modules 2 and 3). The objective is to evaluate the safety and tolerability and anti-tumor activity of EIS-12656 alone or in combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EIS-12656 Dose Escalation | Experimental | Drug: EIS-12656 |
| Dose Expansion Module 1 (EIS-12656 Monotherapy) | Experimental | Drug: EIS-12656 |
| Dose Expansion Module 2 (EIS-12656 + Olaparib) | Experimental | Drug: EIS-12656, Drug: OlaparibEIS-12656 will be given in combination with Olaparib |
| Dose Expansion Module 3 (EIS-12656 + T-DXd) | Experimental | Drug: EIS-12656, Drug: Trastuzumab deruxtecanEIS-12656 will be given in combination with Trastuzumab deruxtecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Recurrent locally advanced or metastatic solid tumors
- Homologous recombination deficient mutations
- Progressed on at least on prior line of treatment or intolerant to additional effective standard therapy
- Measurable disease (RECIST 1.1 Criteria)
- Adequate organ and bone marrow function
Key exclusion criteria (4 listed)
- History or evidence of any clinically relevant gastrointestinal disease
- Radiation therapy within ≤2 weeks
- Significant cardiovascular disease
- Uncontrolled, active, symptomatic brain metastases
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 |
|---|---|---|
| EIS-12656EIS-12656 tablets given daily | Drug | Dose Expansion Module 1 (EIS-12656 Monotherapy), Dose Expansion Module 2 (EIS-12656 + Olaparib), Dose Expansion Module 3 (EIS-12656 + T-DXd), EIS-12656 Dose Escalation |
| Olaparibas per USPI/SmPC | Drug | Dose Expansion Module 2 (EIS-12656 + Olaparib) |
| Trastuzumab deruxtecanAlso: Enhertuas per USPI/SmPC | Drug | Dose Expansion Module 3 (EIS-12656 + T-DXd) |
Primary outcome
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Time frame: From screening until end of treatment follow-up (45 days after last dose) (up to 7 months)
Number and percentage of participants with adverse events, serious adverse events, adverse events of special interest including changes in safety lab parameters, physical examinations, vital signs, and electrocardiogram (ECG)
Number and percentage of participants experiencing a dose limiting toxicity (DLT) (dose escalation part only)
Time frame: Within 21 days of first dose
A DLT is defined as an EIS-12656 related adverse event during the first treatment cycle that meets the criteria outlined in the study protocol
6 secondary outcomes
Maximum plasma concentration of EIS-12656 (Cmax)
Time frame: At pre-defined intervals from pre-dose Day 1 to Day 29
Area under the curve (AUC0-24)
Time frame: At pre-defined intervals from pre-dose Day 1 to Day 29
Time to maximum concentration (Tmax)
Time frame: At pre-defined intervals from pre-dose Day 1 to Day 29
Overall Response Rate
Time frame: From screening to disease progression (approximately 1 year)
Duration of Response
Time frame: From screening to disease progression or death (approximately 1 year)
Progression Free Survival
Time frame: From screening to disease progression or death (approximately 1 year)
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Timothy Yap principal investigator
M.D. Anderson Cancer Center
1 site 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 EIS-12656, Olaparib and Trastuzumab deruxtecan in people with Advanced Solid Tumor and Homologous Recombination Deficiency, run by Eisbach Bio GmbH at 1 site 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 7 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Adrian Schomburg (+49 17621046886, adrian@eisbach.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) (time frame: From screening until end of treatment follow-up (45 days after last dose) (up to 7 months)). 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 19 Sep 2024.