Metastatic Solid TumorPhase 1NCT05479812
Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab (Pembro) in Patients With Selected Advanced or Metastatic Solid Tumors
A Phase 1 study testing WTX-124 and pembrolizumab in people with Metastatic Solid Tumor and Advanced Solid Tumor, run by Werewolf Therapeutics, Inc. at 14 sites in United States.
Trial summary
A first-in-human, Phase I, open-label, multicenter study of WTX-124 administered as monotherapy and in combination with pembrolizumab to patients with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor, Advanced Solid Tumor
- What is being tested?
- WTX-124 and pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 14 sitesUnited States
- Study dates
- 15 Aug 2022to 22 Apr 2026
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each patient must meet all the following criteria to participate in the study:
- Has histological or cytological documentation of a solid tumor indication for which a CPI (e.g. anti-PD-(L)1 is indicated for all parts of the clinical study;
- Monotherapy Dose Escalation:
- Patients with relapsed/refractory locally advanced or metastatic solid tumors for which immunotherapy is approved, who have progressed on or are intolerant to standard therapy, including CPIs, or for whom no standard therapy with proven benefit exists.
- Combination Dose Escalation:
- Patients with relapsed/refractory locally advanced or metastatic solid tumors for which immunotherapy is approved, who have progressed on or are intolerant to standard therapy or for whom no standard therapy with proven benefit exists.
Show all 21Show fewer
- Monotherapy Dose Expansion:
- Arm A: Patients with relapsed advanced or metastatic RCC who have received no more than 4 prior lines of therapy in the advanced or metastatic setting
- Arm B: Patients with relapsed advanced or metastatic cutaneous malignant melanoma who have received no more than 2 prior lines of therapy for BRAF V600 wild type and no more than 3 prior lines of therapy for BRAF V600 mutant melanoma.
- Arm C: Patients with relapsed advanced or metastatic cSCC who have received no more than 2 prior lines of systemic therapy
- Combination Dose Expansion:
- Arm D: Patients with RCC who have received no more than 3 prior lines of therapy
- Arm E: Patients with cutaneous melanoma who may be naïve to all prior therapy for advanced or metastatic disease. For BRAF wild type melanoma, patients should have received no more than 2 prior lines of therapy. For BRAF V600 mutant disease, patients should have received no more than 3 prior lines of therapy.
- Arm F: Patients with PD-L1-positive NSCLC who have received no more than 3 prior lines;
- ≥18 years of age;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Has at least 1 measurable lesion per RECIST 1.1(lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions);
- Agrees to undergo a pre-treatment and on-treatment biopsy of a primary or metastatic solid tumor lesion;
- Has adequate organ and bone marrow function;
- Willingness of men and women of reproductive potential to observe highly effective birth control for the duration of treatment and for 4 months following the last dose of study drug;
- Additional criteria may apply
Who cannot join
- Have a history of another active malignancy (a second cancer) within the previous 2 years except for localized cancers that are not related to the current cancer being treated, are considered cured, and, in the opinion of the Investigator, presents a low risk of recurrence. These exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast;
- Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease;
- Have received prior IL-2-directed therapy;
- Have had an allogeneic tissue/solid organ transplant;
- Have known symptomatic brain metastases requiring steroids;
- Have significant cardiovascular disease;
Show all 20Show fewer
- Have an active autoimmune disease that required systemic treatment in the past 2 years;
- Diagnosis of immunodeficiency, is on immunosuppressive therapy, or is receiving chronic systemic or enteric steroid therapy
- Major surgery (excluding placement of vascular access) within 2 weeks prior to the first dose of study drug;
- Investigational agent or anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug;
- Has received prior radiotherapy within 2 weeks of start of study treatment. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease;
- Any unresolved toxicities from prior therapy greater than NCI CTCAE version 5.0 Grade 1 at the time of starting study drug with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy;
- Received a live or live-attenuated vaccine within 30 days of the first dose of study drug; Note: Administration of killed vaccines or other formats are allowed.
- Active, uncontrolled systemic bacterial, viral, or fungal infection;
- HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease;
- Active infection as determined by hepatitis B surface antigen and hepatitis B core antibody, or hepatitis B virus DNA by quantitative polymerase chain reaction (qPCR) testing;
- Active infection as determined by hepatitis C virus (HCV) antibody or HCV RNA by qPCR testing;
- Pregnant or lactating;
- History of hypersensitivity to any of the study drug components;
- Additional criteria may apply.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Texas Oncology - Austin Midtown
Austin, Texas, 78705-1165
Roswell Park Comprehensive Cancer Care
Buffalo, New York, 14203
Northwestern University
Chicago, Illinois, 60611
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8852
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Westchester Medical Center
Hawthorne, New York, 10532
NEXT Oncology
Houston, Texas, 77054
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, 55369
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
NEXT Oncology
San Antonio, Texas, 78229
HonorHealth
Scottsdale, Arizona, 85258
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Multicenter Phase I/Ib Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced or Metastatic Solid Tumors
A first-in-human, Phase I, open-label, multicenter study of WTX-124 administered as monotherapy and in combination with pembrolizumab to patients with advanced or metastatic solid tumors.
Read the detailed description
This is a first-in-human, Phase I, open-label, multicenter study designed to evaluate the safety, tolerability and preliminary efficacy of WTX-124, a conditionally-activated IL-2 prodrug, when administered as monotherapy and in combination with pembrolizumab, for the treatment of patients with advanced solid tumors. Part 1 of the study is dose escalation of WTX-124, both as monotherapy and in combination with pembrolizumab. Part 2 is dose expansion and is comprised of six arms in which WTX-124 will be administered as monotherapy and in combination with pembrolizumab to patients with advanced or metastatic cutaneous malignant melanoma or advanced or metastatic renal cell carcinoma.
- Conditions
- Metastatic Solid Tumor, Advanced Solid Tumor
- Being tested
- WTX-124, pembrolizumab
- Keywords
- WTX-124, pembrolizumab, Tumors, Cutaneous Malignant Melanoma, mRCC, Renal Carcinoma, IL-2, Cutaneous SCC (cutaneous squamous cell carcinoma), NSCLC (non-small cell lung cancer)
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, Melanoma, Cutaneous Malignant, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WTX-124Drug
Investigation Product Monotherapy
pembrolizumabDrug
Also called KEYTRUDA®
Investigation Product in combination with approved therapy
| Study group | Role | What they receive |
|---|---|---|
| WTX-124 monotherapy dose escalation | Experimental | WTX-124 monotherapy dose escalation Receives: Drug: WTX-124 |
| WTX-124 in combination with pembro dose escalation | Experimental | WTX-124 in combination with pembrolizumab (pembro) dose escalation Receives: Drug: WTX-124; Drug: pembrolizumab |
| Arm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC. | Experimental | Arm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC. Receives: Drug: WTX-124 |
| Arm B: WTX-124 monotherapy dose expansion. Advanced or metastatic cutaneous malignant melanoma. | Experimental | Arm B: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cutaneous malignant melanoma. Receives: Drug: WTX-124 |
| Arm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC. | Experimental | Arm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC. Receives: Drug: WTX-124 |
| Arm D: WTX-124 in combination with pembro dose expansion. Advanced or metastatic RCC. | Experimental | Arm D: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic RCC. Receives: Drug: WTX-124; Drug: pembrolizumab |
| Arm E: WTX-124 with pembro dose expansion. Advanced or metastatic cutaneous melanoma. | Experimental | Arm E: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic cutaneous melanoma. Receives: Drug: WTX-124; Drug: pembrolizumab |
| Arm F: WTX-124 in combination with pembro dose expansion. Advanced/metastatic PD-L1-positive NSCL | Experimental | Arm F: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic PD-L1-positive NSCLC lines. Receives: Drug: WTX-124; Drug: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
Measured: 4 weeks
Incidence of treatment emergent adverse events in monotherapy and combination therapy
Measured: 24 months
Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
Measured: 24 months
Dose Expansion - Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
Measured: 4 weeks
Dose Expansion - Incidence of treatment emergent adverse events in monotherapy and combination therapy
Measured: 24 months
Dose Expansion - Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
Measured: 24 months
Dose Expansion - Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy
Measured: 24 months
Secondary outcomes (12)
Plasma concentrations of WTX-124 and free IL-2
Measured: 24 months
Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy
Measured: 24 months
Changes in circulating immune cell populations in response to monotherapy and combination therapy
Measured: 24 months
Changes in soluble cytokines in response to monotherapy and combination therapy
Measured: 24 months
Changes in tumor immune profile in response to monotherapy and combination therapy
Measured: 24 months
Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy (in advanced or metastatic renal cell carcinoma and advanced or metastatic cutaneous malignant melanoma)
Measured: 24 months
Antidrug antibody (ADA) occurrence
Measured: 24 months
Duration of response
Measured: 24 months
Progression free survival
Measured: 24 months
Overall survival
Measured: 36 months
To investigate immunological biomarkers in peripheral blood and tumor that may correlate with the treatment outcome of WTX-124 as monotherapy or in combination with pembrolizumab
Measured: 24 months
To assess tumor biopsies for potential biomarkers of target engagement and immune pathway activation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start15 Aug 2022
- Primary completion22 Apr 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Werewolf Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479812
- Sponsor's protocol ID
- WTX-124x2101
- Other IDs
- MK-3475-D17, KEYNOTE-D17
- Status last verified
- May 2025
- First submitted
- 14 Jul 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase I/Ib Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05479812
- Acronym / sponsor ID
- WTX-124x2101
- Conditions
- Metastatic Solid Tumor, Advanced Solid Tumor
- Keywords
- WTX-124, pembrolizumab, Tumors, Cutaneous Malignant Melanoma, mRCC, Renal Carcinoma, IL-2, Cutaneous SCC (cutaneous squamous cell carcinoma)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Werewolf Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 29 Jul 2022 (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.
A first-in-human, Phase I, open-label, multicenter study of WTX-124 administered as monotherapy and in combination with pembrolizumab to patients with advanced or metastatic solid tumors.
Detailed description
This is a first-in-human, Phase I, open-label, multicenter study designed to evaluate the safety, tolerability and preliminary efficacy of WTX-124, a conditionally-activated IL-2 prodrug, when administered as monotherapy and in combination with pembrolizumab, for the treatment of patients with advanced solid tumors. Part 1 of the study is dose escalation of WTX-124, both as monotherapy and in combination with pembrolizumab. Part 2 is dose expansion and is comprised of six arms in which WTX-124 will be administered as monotherapy and in combination with pembrolizumab to patients with advanced or metastatic cutaneous malignant melanoma or advanced or metastatic renal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| WTX-124 monotherapy dose escalation | Experimental | Drug: WTX-124WTX-124 monotherapy dose escalation |
| WTX-124 in combination with pembro dose escalation | Experimental | Drug: WTX-124, Drug: pembrolizumabWTX-124 in combination with pembrolizumab (pembro) dose escalation |
| Arm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC. | Experimental | Drug: WTX-124Arm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC. |
| Arm B: WTX-124 monotherapy dose expansion. Advanced or metastatic cutaneous malignant melanoma. | Experimental | Drug: WTX-124Arm B: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cutaneous malignant melanoma. |
| Arm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC. | Experimental | Drug: WTX-124Arm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC. |
| Arm D: WTX-124 in combination with pembro dose expansion. Advanced or metastatic RCC. | Experimental | Drug: WTX-124, Drug: pembrolizumabArm D: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic RCC. |
| Arm E: WTX-124 with pembro dose expansion. Advanced or metastatic cutaneous melanoma. | Experimental | Drug: WTX-124, Drug: pembrolizumabArm E: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic cutaneous melanoma. |
| Arm F: WTX-124 in combination with pembro dose expansion. Advanced/metastatic PD-L1-positive NSCL | Experimental | Drug: WTX-124, Drug: pembrolizumabArm F: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic PD-L1-positive NSCLC lines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Has histological or cytological documentation of a solid tumor indication for which a CPI (e.g. anti-PD-(L)1 is indicated for all parts of the clinical study;
- Monotherapy Dose Escalation:
- Patients with relapsed/refractory locally advanced or metastatic solid tumors for which immunotherapy is approved, who have progressed on or are intolerant to standard therapy, including CPIs, or for whom no standard therapy with proven benefit exists.
- Patients with relapsed/refractory locally advanced or metastatic solid tumors for which immunotherapy is approved, who have progressed on or are intolerant to standard therapy or for whom no standard therapy with proven benefit exists.
- ≥18 years of age;
Key exclusion criteria (20 listed)
- Have a history of another active malignancy (a second cancer) within the previous 2 years except for localized cancers that are not related to the current cancer being treated, are considered cured, and, in the opinion of the Investigator, presents a low risk of recurrence. These exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast;
- Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease;
- Have received prior IL-2-directed therapy;
- Have had an allogeneic tissue/solid organ transplant;
- Have known symptomatic brain metastases requiring steroids;
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 |
|---|---|---|
| WTX-124Investigation Product Monotherapy | Drug | Arm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC., Arm B: WTX-124 monotherapy dose expansion. Advanced or metastatic cutaneous malignant melanoma., Arm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC., Arm D: WTX-124 in combination with pembro dose expansion. Advanced or metastatic RCC., Arm E: WTX-124 with pembro dose expansion. Advanced or metastatic cutaneous melanoma., Arm F: WTX-124 in combination with pembro dose expansion. Advanced/metastatic PD-L1-positive NSCL, WTX-124 in combination with pembro dose escalation, WTX-124 monotherapy dose escalation |
| pembrolizumabAlso: KEYTRUDA®Investigation Product in combination with approved therapy | Drug | Arm D: WTX-124 in combination with pembro dose expansion. Advanced or metastatic RCC., Arm E: WTX-124 with pembro dose expansion. Advanced or metastatic cutaneous melanoma., Arm F: WTX-124 in combination with pembro dose expansion. Advanced/metastatic PD-L1-positive NSCL, WTX-124 in combination with pembro dose escalation |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
Time frame: 4 weeks
Incidence of treatment emergent adverse events in monotherapy and combination therapy
Time frame: 24 months
Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
Time frame: 24 months
Dose Expansion - Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
Time frame: 4 weeks
Dose Expansion - Incidence of treatment emergent adverse events in monotherapy and combination therapy
Time frame: 24 months
Dose Expansion - Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
Time frame: 24 months
Dose Expansion - Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy
Time frame: 24 months
12 secondary outcomes
Plasma concentrations of WTX-124 and free IL-2
Time frame: 24 months
Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy
Time frame: 24 months
Changes in circulating immune cell populations in response to monotherapy and combination therapy
Time frame: 24 months
Changes in soluble cytokines in response to monotherapy and combination therapy
Time frame: 24 months
Changes in tumor immune profile in response to monotherapy and combination therapy
Time frame: 24 months
Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy (in advanced or metastatic renal cell carcinoma and advanced or metastatic cutaneous malignant melanoma)
Time frame: 24 months
Antidrug antibody (ADA) occurrence
Time frame: 24 months
Duration of response
Time frame: 24 months
Progression free survival
Time frame: 24 months
Overall survival
Time frame: 36 months
To investigate immunological biomarkers in peripheral blood and tumor that may correlate with the treatment outcome of WTX-124 as monotherapy or in combination with pembrolizumab
Time frame: 24 months
To assess tumor biopsies for potential biomarkers of target engagement and immune pathway activation
Time frame: 24 months
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 9 Oct 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WTX-124 and pembrolizumab in people with Metastatic Solid Tumor and Advanced Solid Tumor, run by Werewolf Therapeutics, Inc. at 14 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 21 inclusion and 20 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 9 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 14 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 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?
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?
Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy (time frame: 4 weeks). The study lists 7 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 9 Oct 2026.