Solid Tumor, AdultPhase 2BETA-PRIMENCT04673942
A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors
A Phase 2 study testing AdAPT-001 and Checkpoint Inhibitor, Immune in people with Solid Tumor, Adult and Cancer, run by EpicentRx, Inc. at 6 sites in United States.
Trial summary
AdAPT-001 is an oncolytic virus that is injected directly into the tumor or via intraarterial administration. The purpose of this study is to find out if AdAPT-001 is safe and tolerable. The next step is to find out if AdAPT-001 if efficacious with or without a checkpoint inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Cancer, Neoplasms
- What is being tested?
- AdAPT-001 and Checkpoint Inhibitor, Immune
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Mar 2021to 1 Mar 2027
- Phase
- Phase 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
- Subject is capable of understanding the purpose and risks of the study and has provided written Informed Consent.
- Subject is male or female, aged at least 18 years.
- Subject has a histologically or cytologically confirmed diagnosis of an advanced malignant solid tumor(s) who have received all conventional therapies considered appropriate by Investigator and have a tumor that is easily accessible and/or palpable for treatment. Ultrasound guidance may be used to aid administration.
- Subject's Eastern Cooperative Group (ECOG) performance status is 0-1 at Screening.
- Subject has acceptable liver function at Screening, as evidenced by:
- Bilirubin < 1.5 x ULN (upper limit of normal)
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- AST (SGOT) and ALT (SGPT) < 3.0 x ULN (upper limit of normal)
- Alkaline Phosphatase < 2.5 x ULN (upper limit of normal)
- Subject has a Serum Creatinine < 1.5 x ULN (upper limit of normal)
- Subject has acceptable hematologic status at Screening, as evidenced by:
- Absolute neutrophil count > 1,500 cells/mm3; > 1.5 x 109/L, and
- Platelet count > 75,000/mm3; > 75.0 x 109/L, and
- Hemoglobin (HGB) ≥ 8.0 g/dL; ≥ 5.6 mmol/L
- Subject has an INR < 1.5
- Female subjects of childbearing potential (i.e., women who have not been surgically sterilized or have not been post-menopausal for at least one year), and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subject's final dose of AdAPT-001. Medically acceptable contraception is defined as either: 1) usage by at least one of the partners of a barrier method of contraception, together with usage by the female partner, commencing at least three months prior to Study Day 1, of a stable regimen of any form of hormonal contraception or an intra-uterine device, or 2) usage by the couple of a double-barrier method of contraception. Use of a single-barrier method alone or abstinence alone is not considered adequate.
- Subject is willing and able to comply with all protocol procedures, evaluations and rescue measures.
- OPTIONAL: Archival formalin-fixed paraffin-embedded block(s) or previously cut archival tissue for at least 5 unstained slides (if available).
Who cannot join
- Presence of a serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder.
- A known uncontrolled active bacterial, fungal, or viral infection. No subject with an active SARS-CoV-2 infection (within 14 days of a positive test)
- Known positive history of human immunodeficiency virus (HIV) test
- Subjects who have active hepatitis.
- If female, subject is pregnant and/or breastfeeding.
- Subjects with active autoimmune disease or history of autoimmune disease that might recur and may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded.
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- Note: Subjects in any condition requiring systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent of the similar drug) or other immunosuppressive agents within 14 days before AdAPT-001), but currently or previously treated with any of the following steroid regimens were included: Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; prophylactic short-term use of corticosteroids.
- Prior adenoviral therapy for any indication except vaccination against infectious disease. Subjects receiving COVID-19 or live vaccination, cannot start treatment until 7 days after completing the vaccination. Recommend waiting at least 28 days from AdAPT-001 dose prior to receiving COVID-19 vaccination. Concurrent treatment with Evusheld is allowed.
- Chemotherapy or immunotherapy within 14 days of study treatment. Hormonal therapy (including tamoxifen, aromatase inhibitors, and gonadotropin releasing hormone agonists) is allowed. Concurrent treatment with bisphosphonate and RANK ligand inhibitor is allowed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Mary Crowley Cancer Research
Dallas, Texas, 75230
City of Hope
Duarte, California, 91010
MD Anderson Cancer Center
Houston, Texas, 77030
California Cancer Associates for Research and Excellence, cCARE
San Marcos, California, 92069
Providence Saint John's Health Center
Santa Monica, California, 90404
About this study
Official title: An Adapted Phase 2a/2b, Study to Evaluate the Safety, Tolerability, and Efficacy of AdAPT-001 in Subjects With Refractory Solid Tumors
AdAPT-001 is an oncolytic virus that is injected directly into the tumor or via intraarterial administration. The purpose of this study is to find out if AdAPT-001 is safe and tolerable. The next step is to find out if AdAPT-001 if efficacious with or without a checkpoint inhibitor.
Read the detailed description
This is a dose escalation protocol to determine, first and foremost, the safety, tolerability and feasibility of intratumoral administration of AdAPT-001.
The study has 3 parts. Different groups of patients will participate in each part.
PHASE 1 PART 1: Dose Escalation Safety Run-In (CLOSED - Enrollment Completed) During PART 1, all participants will be treated with AdAPT-001 as a single injection, one time. Participants will be assigned to different dose levels to find the highest dose of AdAPT-001 that is safe and tolerable.
PHASE 1 PART 2: Dose Expansion Single-Agent (CLOSED - Enrollment Completed) All participants in PART 2 will receive injections of AdAPT-001 on Days 1 and 15 of 28-day cycles.
PHASE 1 PART 3: Expansion (CLOSED - Enrollment Completed) Subjects will be assigned to the following two arms. If a checkpoint inhibitor is indicated for the subject, the subject may be enrolled on Arm 2 per investigator discretion, otherwise subjects may be enrolled on Arm 1.
Arm 1: Intratumoral administration of AdAPT-001 (1.0 x 10¹² viral particles) on Day 1 and 15 of each 28-day cycle for up to 12 injections.
Arm 2: Intratumoral administration of AdAPT-001 (1.0 x 10¹² viral particles) on Day 1 and 15 of each 28-day cycle for up to 12 injections plus a checkpoint inhibitor per investigator discretion
PHASE 2: (OPEN to Enrollment)
Subjects with advanced solid tumors will participate in a basket two-arm parallel group evaluation (Phase 2) where eligible participants will be assigned to the following two arms based on confirmed histology by the treating investigator.
Arm 1: Confirmed Histological Diagnosis of Sarcoma Intratumoral Administration of AdAPT-001 (1.0 x 10¹² viral particles) on Day 1 and 15 of each 28-day cycle for up to 12 injections with or without a checkpoint inhibitor.
Arm 2: Confirmed Histological Diagnosis of Advanced Solid Tumor indicated to receive at least one checkpoint inhibitor.
- Conditions
- Solid Tumor, Adult, Cancer, Neoplasms, Sarcoma, Sarcoma,Soft Tissue, Chondrosarcoma
- Being tested
- AdAPT-001, Checkpoint Inhibitor, Immune
- Keywords
- oncolytic virus, immunotherapy, adenovirus, intratumoral injection, AdAPT-001, Sarcoma
- Medical subject headings
- Neoplasms, Sarcoma, Chondrosarcoma, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdAPT-001Biological
Oncolytic virus administered by intratumoral injection
Checkpoint Inhibitor, ImmuneDrug
Checkpoint Inhibitor per investigator discretion based on diagnosis and subject tolerability
| Study group | Role | What they receive |
|---|---|---|
| PART 1: Dose Escalation Safety Run-In (Enrollment Completed) | Experimental | Subjects will be treated with AdAPT-001 as a single injection, one time. Receives: Biological: AdAPT-001 |
| PART 2: Dose Expansion Single-Agent (Enrollment Completed) | Experimental | 6 subjects will be enrolled in the Lead In Cohort. A Safety Analysis will be performed after 6 subjects have received at least 24 doses. Upon Safety team review as a continuous reassessment of safety, an additional 19 subjects may be enrolled. All subjects in PART 2 will receive injections of AdAPT-001 on Days 1 and 15 of 28-day cycles. Receives: Biological: AdAPT-001 |
| PART 3: Expansion (Enrollment Completed) | Experimental | Up to 45 subjects will be enrolled in the expansion cohort to receive either AdAPT-001 on Days 1 and 15 of 28-day cycles or AdAPT-001 on Days 1 and 15 plus a checkpoint inhibitor of 28-day cycles. Receives: Biological: AdAPT-001; Drug: Checkpoint Inhibitor, Immune |
| Phase 2 (Enrollment Open) | Experimental | Approximately 55 to 80 subjects with advanced solid tumors including sarcoma to receive either AdAPT-001 on Days 1 and 15 of 28-day cycles or AdAPT-001 on Days 1 and 15 plus a checkpoint inhibitor of 28-day cycles.. Receives: Biological: AdAPT-001; Drug: Checkpoint Inhibitor, Immune |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT)
All subjects in PART 1 will be assessed for the development of dose-limiting toxicity (DLT) during treatment with AdAPT-001. The DLT assessment period is defined as: Day of Injection through 28 days post injection (Safety Follow Up). A DLT will be defined as any Grade 3 or higher adverse event, as assessed by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 28 days
Maximum tolerated dose
In PART 1, A MTD is determined if any cohort experiences 2 subjects with DLT's.
Measured: 28 days
Safety of a multiple dose regimen of AdAPT-001
The safety data will include adverse events, serious adverse events, performance status, clinical laboratory tests, vital signs and physical examination results.
Measured: 6 months
Anti-tumor activity of the two-arm dose regimens of AdAPT-001 in Phase 2
To evaluate the efficacy of the two-arm dose regimens of AdAPT-001 in subjects with advanced solid tumors that have progressed after treatment with standard therapies or for which there are no appropriate therapies available as measured by durable (≥4 months) stable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: 6 months
Secondary outcomes (2)
Anti-tumor activity of AdAPT-001
In PART 2 and PART 3, overall response rate (ORR) and best overall response rates per response evaluation criteria outlined in Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), as well as progression-free survival (PFS), and duration of response will be assessed.
Measured: 6 months
Objective response rate
Preliminarily to assess anti-tumor activity of AdAPT-001 by objective response rates (ORR) and best overall response rates per response evaluation criteria outlined in RECIST guideline (Version 1.1),
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start29 Mar 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study is an exploratory open label single-arm interventional study using a 3 + 3 dose escalation safety run-in (PART 1) followed by a dose expansion single-agent (PART 2), followed by expansion (PART 3) single agent or single agent plus checkpoint inhibitor, followed by an adaptive designed Phase 2..
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EpicentRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bryan Oronsky, MD PhD, Study director, EpicentRx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673942
- Sponsor's protocol ID
- BETA-PRIME
- Acronym
- BETA-PRIME
- Status last verified
- Jun 2026
- First submitted
- 8 Dec 2020
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Reid TR, Oronsky B, Williams J, Caroen S, Conley A. TGF-beta trap of AdAPT-001 turns up the heat on tumors and turns down checkpoint blocker resistance. J Immunother Cancer. 2024 Oct 26;12(10):e009613. doi: 10.1136/jitc-2024-009613.
PubMed 39461878Kesari S, Bessudo A, Gastman BR, Conley AP, Villaflor VM, Nabell LM, Madere D, Chacon E, Spencer C, Li L, Larson C, Reid T, Caroen S, Oronsky B, Stirn M, Williams J, Barve MA. BETA PRIME: Phase I study of AdAPT-001 as monotherapy and combined with a checkpoint inhibitor in superficially accessible, treatment-refractory solid tumors. Future Oncol. 2022 Sep;18(29):3245-3254. doi: 10.2217/fon-2022-0481. Epub 2022 Aug 11.
PubMed 35950603
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adapted Phase 2a/2b, Study to Evaluate the Safety, Tolerability, and Efficacy of AdAPT-001 in Subjects With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT04673942
- Acronym / sponsor ID
- BETA-PRIME / BETA-PRIME
- Conditions
- Solid Tumor, Adult, Cancer, Neoplasms, Sarcoma, Sarcoma,Soft Tissue, Chondrosarcoma
- Keywords
- oncolytic virus, immunotherapy, adenovirus, intratumoral injection, AdAPT-001, Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- EpicentRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 17 Dec 2020 (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.
AdAPT-001 is an oncolytic virus that is injected directly into the tumor or via intraarterial administration. The purpose of this study is to find out if AdAPT-001 is safe and tolerable. The next step is to find out if AdAPT-001 if efficacious with or without a checkpoint inhibitor.
Detailed description
This is a dose escalation protocol to determine, first and foremost, the safety, tolerability and feasibility of intratumoral administration of AdAPT-001.
The study has 3 parts. Different groups of patients will participate in each part.
PHASE 1 PART 1: Dose Escalation Safety Run-In (CLOSED - Enrollment Completed) During PART 1, all participants will be treated with AdAPT-001 as a single injection, one time. Participants will be assigned to different dose levels to find the highest dose of AdAPT-001 that is safe and tolerable.
PHASE 1 PART 2: Dose Expansion Single-Agent (CLOSED - Enrollment Completed) All participants in PART 2 will receive injections of AdAPT-001 on Days 1 and 15 of 28-day cycles.
PHASE 1 PART 3: Expansion (CLOSED - Enrollment Completed) Subjects will be assigned to the following two arms. If a checkpoint inhibitor is indicated for the subject, the subject may be enrolled on Arm 2 per investigator discretion, otherwise subjects may be enrolled on Arm 1.
Arm 1: Intratumoral administration of AdAPT-001 (1.0 x 10¹² viral particles) on Day 1 and 15 of each 28-day cycle for up to 12 injections.
Arm 2: Intratumoral administration of AdAPT-001 (1.0 x 10¹² viral particles) on Day 1 and 15 of each 28-day cycle for up to 12 injections plus a checkpoint inhibitor per investigator discretion
PHASE 2: (OPEN to Enrollment)
Subjects with advanced solid tumors will participate in a basket two-arm parallel group evaluation (Phase 2) where eligible participants will be assigned to the following two arms based on confirmed histology by the treating investigator.
Arm 1: Confirmed Histological Diagnosis of Sarcoma Intratumoral Administration of AdAPT-001 (1.0 x 10¹² viral particles) on Day 1 and 15 of each 28-day cycle for up to 12 injections with or without a checkpoint inhibitor.
Arm 2: Confirmed Histological Diagnosis of Advanced Solid Tumor indicated to receive at least one checkpoint inhibitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study is an exploratory open label single-arm interventional study using a 3 + 3 dose escalation safety run-in (PART 1) followed by a dose expansion single-agent (PART 2), followed by expansion (PART 3) single agent or single agent plus checkpoint inhibitor, followed by an adaptive designed Phase 2..
| Arm | Type | Receives |
|---|---|---|
| PART 1: Dose Escalation Safety Run-In (Enrollment Completed) | Experimental | Biological: AdAPT-001Subjects will be treated with AdAPT-001 as a single injection, one time. |
| PART 2: Dose Expansion Single-Agent (Enrollment Completed) | Experimental | Biological: AdAPT-0016 subjects will be enrolled in the Lead In Cohort. A Safety Analysis will be performed after 6 subjects have received at least 24 doses. Upon Safety team review as a continuous reassessment of safety, an additional 19 subjects may be enrolled. All subjects in PART 2 will receive injections of AdAPT-001 on Days 1 and 15 of 28-day cycles. |
| PART 3: Expansion (Enrollment Completed) | Experimental | Biological: AdAPT-001, Drug: Checkpoint Inhibitor, ImmuneUp to 45 subjects will be enrolled in the expansion cohort to receive either AdAPT-001 on Days 1 and 15 of 28-day cycles or AdAPT-001 on Days 1 and 15 plus a checkpoint inhibitor of 28-day cycles. |
| Phase 2 (Enrollment Open) | Experimental | Biological: AdAPT-001, Drug: Checkpoint Inhibitor, ImmuneApproximately 55 to 80 subjects with advanced solid tumors including sarcoma to receive either AdAPT-001 on Days 1 and 15 of 28-day cycles or AdAPT-001 on Days 1 and 15 plus a checkpoint inhibitor of 28-day cycles.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subject is capable of understanding the purpose and risks of the study and has provided written Informed Consent.
- Subject is male or female, aged at least 18 years.
- Subject has a histologically or cytologically confirmed diagnosis of an advanced malignant solid tumor(s) who have received all conventional therapies considered appropriate by Investigator and have a tumor that is easily accessible and/or palpable for treatment. Ultrasound guidance may be used to aid administration.
- Subject's Eastern Cooperative Group (ECOG) performance status is 0-1 at Screening.
- Subject has acceptable liver function at Screening, as evidenced by:
Key exclusion criteria (9 listed)
- Presence of a serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder.
- A known uncontrolled active bacterial, fungal, or viral infection. No subject with an active SARS-CoV-2 infection (within 14 days of a positive test)
- Known positive history of human immunodeficiency virus (HIV) test
- Subjects who have active hepatitis.
- If female, subject is pregnant and/or breastfeeding.
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 |
|---|---|---|
| AdAPT-001Oncolytic virus administered by intratumoral injection | Biological | PART 1: Dose Escalation Safety Run-In (Enrollment Completed), PART 2: Dose Expansion Single-Agent (Enrollment Completed), PART 3: Expansion (Enrollment Completed), Phase 2 (Enrollment Open) |
| Checkpoint Inhibitor, ImmuneCheckpoint Inhibitor per investigator discretion based on diagnosis and subject tolerability | Drug | PART 3: Expansion (Enrollment Completed), Phase 2 (Enrollment Open) |
Primary outcome
Dose Limiting Toxicities (DLT)
Time frame: 28 days
All subjects in PART 1 will be assessed for the development of dose-limiting toxicity (DLT) during treatment with AdAPT-001. The DLT assessment period is defined as: Day of Injection through 28 days post injection (Safety Follow Up). A DLT will be defined as any Grade 3 or higher adverse event, as assessed by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Maximum tolerated dose
Time frame: 28 days
In PART 1, A MTD is determined if any cohort experiences 2 subjects with DLT's.
Safety of a multiple dose regimen of AdAPT-001
Time frame: 6 months
The safety data will include adverse events, serious adverse events, performance status, clinical laboratory tests, vital signs and physical examination results.
Anti-tumor activity of the two-arm dose regimens of AdAPT-001 in Phase 2
Time frame: 6 months
To evaluate the efficacy of the two-arm dose regimens of AdAPT-001 in subjects with advanced solid tumors that have progressed after treatment with standard therapies or for which there are no appropriate therapies available as measured by durable (≥4 months) stable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
2 secondary outcomes
Anti-tumor activity of AdAPT-001
Time frame: 6 months
Objective response rate
Time frame: 6 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 26 Jun 2026.
- Derived from this study: PubMed 39461878Reid TR, Oronsky B, Williams J, Caroen S, Conley A. TGF-beta trap of AdAPT-001 turns up the heat on tumors and turns down checkpoint blocker resistance. J Immunother Cancer. 2024 Oct 26;12(10):e009613. doi: 10.1136/jitc-2024-009613.
- Derived from this study: PubMed 35950603Kesari S, Bessudo A, Gastman BR, Conley AP, Villaflor VM, Nabell LM, Madere D, Chacon E, Spencer C, Li L, Larson C, Reid T, Caroen S, Oronsky B, Stirn M, Williams J, Barve MA. BETA PRIME: Phase I study of AdAPT-001 as monotherapy and combined with a checkpoint inhibitor in superficially accessible, treatment-refractory solid tumors. Future Oncol. 2022 Sep;18(29):3245-3254. doi: 10.2217/fon-2022-0481. Epub 2022 Aug 11.
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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.
Bryan Oronsky, MD PhD study director
EpicentRx, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AdAPT-001 and Checkpoint Inhibitor, Immune in people with Solid Tumor, Adult and Cancer, run by EpicentRx, Inc. at 6 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 17 inclusion and 9 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 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 phase mean?
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?
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?
Dose Limiting Toxicities (DLT) (time frame: 28 days). 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?
On the ClinicalTrials.gov record for NCT04673942, which also lists 2 linked publications.
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 26 Jun 2026.