CancerPhase 1NCT06533059
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
A Phase 1 study testing ALTA2618 in people with Cancer and Breast Cancer, run by Alterome Therapeutics, Inc. at 31 sites in 8 countries.
Trial summary
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast Cancer, Endometrial Cancer
- What is being tested?
- ALTA2618
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 31 sitesin 8 countries
- Study dates
- 22 Aug 2024to 29 Dec 2027
- Phase
- Phase 1
- 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
- Histologically confirmed diagnosis of a solid tumor malignancy harboring AKT1 E17K mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.
- Unresectable or metastatic disease
- Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage
- Evaluable or measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
Who cannot join
- Prior treatment with PI3K and/or mTOR inhibitors
- Patients known to have KRAS, NRAS, HRAS, or BRAF genomic alterations in their tumor
- Known condition that prohibits ability to swallow or absorb an oral medication
- Other inclusion/exclusion criteria may apply.
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
United States12 sites
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02215
Research Site
Denver, Colorado, 80218
Research Site
Fairfax, Virginia, 22031
Research Site
Houston, Texas, 77030
Research Site
La Jolla, California, 92093
Research Site
Madison, Wisconsin, 53792
Research Site
Nashville, Tennessee, 37203
Research Site #2
San Antonio, Texas, 78229
Research Site
San Antonio, Texas, 78229
Research Site
Sarasota, Florida, 34232
Research Site
St Louis, Missouri, 63110
United Kingdom5 sites
Research Site
London, SW3 6JJ
Research Site
London, W1G 6AD
Research Site
Manchester, M10 4BX
Research Site
Newcastle upon Tyne, NE7 7DN
Research Site
Sutton, SM2 5PT
Spain4 sites
Research Site
Barcelona, 08035
Research Site
Barcelona, 08908
Research Site
Madrid, 28023
Research Site
Madrid, 28040
Australia3 sites
Research Site
Malvern, Victoria, 3144
Research Site
Nedlands, Western Australia, 6009
Research Site
Randwick, New South Wales, 2031
About this study
Official title: AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
Read the detailed description
This is an open-label, multicenter, Phase 1/1b study of ALTA2618, a mutant-selective and orally bioavailable AKT1 E17K inhibitor, in adults with AKT1 E17K-mutant solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA2618, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
- Being tested
- ALTA2618
- Keywords
- AKT1 E17K, Breast cancer, Breast carcinoma, Breast neoplasm, ER positive breast, HR positive breast, Triple negative breast cancer, Gynecologic cancer, Gynecologic neoplasm, Gynecologic carcinoma, Endometrial cancer, Endometrial neoplasm, Endometrial carcinoma, Cervical cancer, Cervical neoplasm, Cervical carcinoma, Ovarian cancer, Ovarian carcinoma, Ovarian neoplasm, Fallopian cancer
- Medical subject headings
- Neoplasms, Breast Neoplasms, Endometrial Neoplasms, Neoplasm Metastasis, Triple Negative Breast Neoplasms, Genital Neoplasms, Female, Uterine Cervical Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALTA2618Drug
Oral ALTA2618 tablets will be administered at protocol-defined dose
| Study group | Role | What they receive |
|---|---|---|
| ALTA2618 | Experimental | ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment Receives: Drug: ALTA2618 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants that experience treatment-emergent adverse events (TEAEs).
Measured: Up to 39 months
Dose Limiting Toxicities
Number of participants with Dose Limiting Toxicities (DLTs).
Measured: 21 days
Secondary outcomes (8)
Maximum Observed Plasma Concentration (Cmax)
Cmax
Measured: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax
Measured: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)
AUCt
Measured: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Terminal Half-Life (t1/2)
t1/2
Measured: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose
Overall Response Rate (ORR)
Assess per RECIST 1.1
Measured: Up to 39 months
Duration of Response (DOR)
Assess per RECIST 1.1
Measured: Up to 39 months
Progression-Free Survival (PFS)
Assess per RECIST 1.1
Measured: Up to 39 months
Overall Survival (OS)
Assess per RECIST 1.1
Measured: Up to 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start22 Aug 2024
- Primary completion29 Dec 2026 (estimated)
- Study completion29 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alterome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Medical Director, Study director, Alterome Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533059
- Sponsor's protocol ID
- 2618-001
- Status last verified
- Mar 2026
- First submitted
- 25 Jul 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation
- ClinicalTrials.gov ID
- NCT06533059
- Acronym / sponsor ID
- 2618-001
- Keywords
- AKT1 E17K, Breast cancer, Breast carcinoma, Breast neoplasm, ER positive breast, HR positive breast, Triple negative breast cancer, Gynecologic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Alterome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 29 Dec 2027 (estimated)
- First posted
- 1 Aug 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.
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
Detailed description
This is an open-label, multicenter, Phase 1/1b study of ALTA2618, a mutant-selective and orally bioavailable AKT1 E17K inhibitor, in adults with AKT1 E17K-mutant solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA2618, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALTA2618 | Experimental | Drug: ALTA2618ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed diagnosis of a solid tumor malignancy harboring AKT1 E17K mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.
- Unresectable or metastatic disease
- Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage
- Evaluable or measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (4 listed)
- Prior treatment with PI3K and/or mTOR inhibitors
- Patients known to have KRAS, NRAS, HRAS, or BRAF genomic alterations in their tumor
- Known condition that prohibits ability to swallow or absorb an oral medication
- Other inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| ALTA2618Oral ALTA2618 tablets will be administered at protocol-defined dose | Drug | ALTA2618 |
Primary outcome
Adverse Events
Time frame: Up to 39 months
Number of participants that experience treatment-emergent adverse events (TEAEs).
Dose Limiting Toxicities
Time frame: 21 days
Number of participants with Dose Limiting Toxicities (DLTs).
8 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)
Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Terminal Half-Life (t1/2)
Time frame: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose
Overall Response Rate (ORR)
Time frame: Up to 39 months
Duration of Response (DOR)
Time frame: Up to 39 months
Progression-Free Survival (PFS)
Time frame: Up to 39 months
Overall Survival (OS)
Time frame: Up to 39 months
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 15 Jul 2026.
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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. This study is not recruiting at the moment.
Study Medical Director study director
Alterome Therapeutics
31 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALTA2618 in people with Cancer and Breast Cancer, run by Alterome Therapeutics, Inc. at 31 sites in 8 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 6 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, United Kingdom, Spain, Australia, France and 3 more countries. 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 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.
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?
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?
Adverse Events (time frame: Up to 39 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 15 Jul 2026.