Metastatic Colorectal CancerPhase 2NCT07503756
JS212 Combination Therapies in Metastatic Colorectal Cancer
A Phase 2 study testing JS212, Capecitabine and Bevacizumab in people with Metastatic Colorectal Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, multicenter Phase 2 clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212-based combination therapies in patients with metastatic colorectal cancer (mCRC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- JS212, Capecitabine and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2026to 30 Mar 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1Participants must meet the following key criteria
- Adults aged 18-75 years with histologically confirmed metastatic colorectal adenocarcinoma
- Microsatellite stable (MSS) or mismatch repair proficient (pMMR) disease
- No prior systemic therapy for advanced or metastatic disease
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status 0-1
Show all 10Show fewer
- Adequate hematologic, hepatic, renal, and coagulation function
- Life expectancy ≥12 weeks
- Willingness to provide tumor tissue samples for biomarker analyses
- Ability to provide written informed consent
Who cannot join
- Participants meeting any of the following criteria will be excluded
- Prior treatment with EGFR- or HER3-targeted antibody-drug conjugates or topoisomerase I inhibitor-based ADCs
- Recent major surgery, radiotherapy, or systemic anticancer therapy prior to study treatment
- Active or uncontrolled infections or significant cardiovascular disease
- Known active central nervous system metastases
- History of autoimmune disease requiring systemic therapy
Show all 9Show fewer
- Significant bleeding disorders or high risk of hemorrhage
- Active viral infections such as uncontrolled hepatitis B, hepatitis C, or HIV
- Any other serious medical or psychiatric condition that may interfere with study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Yong Gao, Ph.D, 86 21-38804518, drgaoyong@163.com
Yong Gao, Ph.D
About this study
Official title: An Open-label, Multicenter Phase 2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JS212 Combination Therapies in Patients With Metastatic Colorectal Cancer
This is an open-label, multicenter Phase 2 clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212-based combination therapies in patients with metastatic colorectal cancer (mCRC).
JS212 is a bispecific antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and HER3 with a topoisomerase I inhibitor payload. Preclinical and early clinical data suggest that dual targeting of EGFR and HER3 may enhance antitumor activity and overcome resistance mechanisms associated with EGFR- or HER2-directed therapies.
Read more
This study will investigate JS212 in combination with capecitabine, with or without Bevacizumab, and JS212 in combination with chemotherapy (XELOX: capecitabine and oxaliplatin), with or without the PD-1/VEGF bispecific antibody JS207, in patients with mCRC.
The study will assess safety, determine the recommended Phase 3 dose (RP3D), and evaluate preliminary antitumor activity of the combination regimens.
Read the detailed description
JS212 is a bispecific antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and HER3, conjugated with a topoisomerase I inhibitor payload. Activation of EGFR and HER3 signaling pathways plays an important role in tumor development and resistance to anticancer therapies. Dual targeting of these pathways may enhance antitumor activity and broaden the population that may benefit from treatment. Early clinical data from study JS212-001-I/II have demonstrated promising safety and antitumor activity of JS212.
In addition, ADCs may induce immunogenic cell death and enhance antitumor immune responses. Combination therapy with immune checkpoint inhibitors may further enhance therapeutic efficacy. JS207 is a bispecific antibody targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), which may provide synergistic antitumor effects by simultaneously modulating immune checkpoint signaling and tumor angiogenesis.
This study will evaluate JS212 in combination with capecitabine, with or without Bevacizumab, and JS212 in combination with chemotherapy (capecitabine and oxaliplatin, XELOX), with or without JS207, in patients with mCRC.
The study includes 4 cohorts:
Cohort 1: JS212 in combination with capecitabine. A dose-escalation phase using a Bayesian optimal interval (BOIN) design will be conducted to determine the maximum tolerated dose (MTD) and recommended Phase 3 dose (RP3D), followed by a dose-expansion phase to further evaluate safety and efficacy.
Cohort 2: JS212 in combination with capecitabine and Bevacizumab. A safety run-in phase will be conducted to evaluate tolerability of the triple combination, followed by a dose-expansion phase to further assess safety and preliminary antitumor activity.
Cohort 3: JS212 in combination with XELOX chemotherapy. safety run-in phase will be conducted to evaluate tolerability of the triple combination, followed by a dose-expansion phase to further assess safety and preliminary antitumor activity.
Cohort 4: JS212 in combination with XELOX chemotherapy and JS207. A safety run-in phase will be conducted to evaluate tolerability of the triple combination, followed by a dose-expansion phase to further assess safety and preliminary antitumor activity.
Eligible participants include adults with histologically confirmed metastatic colorectal adenocarcinoma that is microsatellite stable or mismatch repair proficient and who have not received prior systemic therapy for advanced disease.
The study will evaluate safety, pharmacokinetics, immunogenicity, and preliminary efficacy outcomes including objective response rate (ORR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) based on RECIST version 1.1.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- JS212, Capecitabine, Bevacizumab, Oxaliplatin, JS207
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS212Drug
Bispecific antibody-drug conjugate targeting EGFR and HER3
CapecitabineDrug
Oral fluoropyrimidine chemotherapy
BevacizumabDrug
Humanized anti-VEGF monoclonal antibody
OxaliplatinDrug
Platinum-based chemotherapy administered intravenously
JS207Drug
Bispecific antibody targeting PD-1 and VEGF
| Study group | Role | What they receive |
|---|---|---|
| JS212 + Capecitabine | Experimental | Participants receive JS212 in combination with Capecitabine. Receives: Drug: JS212; Drug: Capecitabine |
| JS212 +Capecitabine+ Bevacizumab | Experimental | Participants receive JS212 in combination with Capecitabine and Bevacizumab Receives: Drug: JS212; Drug: Capecitabine; Drug: Bevacizumab |
| JS212 + XELOX | Experimental | Participants receive JS212 in combination with XELOX chemotherapy (capecitabine plus oxaliplatin) Receives: Drug: JS212; Drug: Capecitabine; Drug: Oxaliplatin |
| JS212 + XELOX + JS207 | Experimental | Participants receive JS212 in combination with XELOX chemotherapy and JS207 Receives: Drug: JS212; Drug: Capecitabine; Drug: Oxaliplatin; Drug: JS207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed objective response rate (ORR)
Proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
Measured: Up to approximately 12 months
Safety and Tolerability(AEs)
Incidence and severity of adverse events (AEs) assessed according to CTCAE.
Measured: From first dose up to approximately 90 days after last dose
Safety and Tolerability(SAEs)
Incidence and severity of serious adverse events (SAEs)assessed according to CTCAE.
Measured: From first dose up to approximately 90 days after last dose
Safety and Tolerability(DLTs)
Incidence and severity dose-limiting toxicities (DLTs) assessed according to CTCAE.
Measured: From first dose up to approximately 90 days after last dose
Maximum Tolerated Dose (MTD)
Determination of MTD for JS212 combination therapy.
Measured: Up to approximately 6 months
Recommended Phase 3 Dose (RP3D)
Determination of RP3D for JS212 combination therapy.
Measured: Up to approximately 6 months
Secondary outcomes (8)
Investigator-assessed objective response rate (DCR)
The DCR is defined as the proportion of subjects whose Best Overall Response (BOR) is Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Measured: Up to approximately 12 months
Investigator-assessed Duration of Response (DoR)
The DoR is defined as the time from the first occurrence of CR or PR to the first occurrence of Progressive Disease (PD) or death (whichever occurs first). The DoR is only applicable to subjects whose BOR is CR or PR.
Measured: Up to approximately 12 months
Investigator-assessed Progression-Free Survival (PFS)
The PFS is defined as the time from the first administration of the drug to the first documented disease progression (PD) according to the RECIST v1.1 criteria or death due to any disease (whichever occurs first).
Measured: Up to approximately 12 months
Investigator-assessed overall survival (OS)
The OS is defined as the time from the first administration of the drug to death due to any cause.
Measured: Up to approximately 20 months
PK of Cmax
Maximum Observed Plasma Concentration (Cmax) of JS212 and JS207
Measured: Up to approximately 12 months
PK of AUC
Area Under the Concentration-Time Curve of JS212 and JS207
Measured: Up to approximately 12 months
PK of half-time
Terminal Elimination Half-life of JS212 and JS207
Measured: Up to approximately 12 months
Immunogenicity
Incidence of anti-drug antibodies (ADA) and neutralizing antibodies.
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start25 Apr 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a phaseII, open-label, multicenter study in previously untreated MSS/pMMR advanced colorectal cancer, evaluating JS212+Capecitabine (Cohort 1), JS212+Capecitabine+Bevacizumab (Cohort 2), JS212 + XELOX (Cohort 3) and JS212 + XELOX + JS207 (Cohort 4). Cohort 1: A dose-escalation phase (JS212 Q3W +Capecitabine) will select 1-2 RP2Ds, followed by a dose-expansion phase to assess safety, efficacy. Cohort 2: After confirming Cohort 1's RP2D, a safety lead-in phase will evaluate JS212 (RP2D) + Capecitabine + Bevacizumab Q3W. A dose-expansion phase will further assess safety, efficacy. Cohort 3: After confirming Cohort 1's RP2D, a safety lead-in phase will evaluate JS212 (RP2D) + XELOX Q3W. A dose-expansion phase will further assess safety, efficacy. Cohort 4: After confirming Cohort 1's RP2D, a safety lead-in phase will evaluate JS212 (RP2D) + XELOX + JS207 Q3W. A dose-expansion phase will further assess safety, efficacy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenyu Xu, Doctor, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503756
- Sponsor's protocol ID
- JS212-005-II-CRC
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase 2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JS212 Combination Therapies in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07503756
- Acronym / sponsor ID
- JS212-005-II-CRC
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 31 Mar 2026 (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 is an open-label, multicenter Phase 2 clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212-based combination therapies in patients with metastatic colorectal cancer (mCRC).
JS212 is a bispecific antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and HER3 with a topoisomerase I inhibitor payload. Preclinical and early clinical data suggest that dual targeting of EGFR and HER3 may enhance antitumor activity and overcome resistance mechanisms associated with EGFR- or HER2-directed therapies.
This study will investigate JS212 in combination with capecitabine, with or without Bevacizumab, and JS212 in combination with chemotherapy (XELOX: capecitabine and oxaliplatin), with or without the PD-1/VEGF bispecific antibody JS207, in patients with mCRC.
The study will assess safety, determine the recommended Phase 3 dose (RP3D), and evaluate preliminary antitumor activity of the combination regimens.
Detailed description
JS212 is a bispecific antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and HER3, conjugated with a topoisomerase I inhibitor payload. Activation of EGFR and HER3 signaling pathways plays an important role in tumor development and resistance to anticancer therapies. Dual targeting of these pathways may enhance antitumor activity and broaden the population that may benefit from treatment. Early clinical data from study JS212-001-I/II have demonstrated promising safety and antitumor activity of JS212.
In addition, ADCs may induce immunogenic cell death and enhance antitumor immune responses. Combination therapy with immune checkpoint inhibitors may further enhance therapeutic efficacy. JS207 is a bispecific antibody targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), which may provide synergistic antitumor effects by simultaneously modulating immune checkpoint signaling and tumor angiogenesis.
This study will evaluate JS212 in combination with capecitabine, with or without Bevacizumab, and JS212 in combination with chemotherapy (capecitabine and oxaliplatin, XELOX), with or without JS207, in patients with mCRC.
The study includes 4 cohorts:
Cohort 1: JS212 in combination with capecitabine. A dose-escalation phase using a Bayesian optimal interval (BOIN) design will be conducted to determine the maximum tolerated dose (MTD) and recommended Phase 3 dose (RP3D), followed by a dose-expansion phase to further evaluate safety and efficacy.
Cohort 2: JS212 in combination with capecitabine and Bevacizumab. A safety run-in phase will be conducted to evaluate tolerability of the triple combination, followed by a dose-expansion phase to further assess safety and preliminary antitumor activity.
Cohort 3: JS212 in combination with XELOX chemotherapy. safety run-in phase will be conducted to evaluate tolerability of the triple combination, followed by a dose-expansion phase to further assess safety and preliminary antitumor activity.
Cohort 4: JS212 in combination with XELOX chemotherapy and JS207. A safety run-in phase will be conducted to evaluate tolerability of the triple combination, followed by a dose-expansion phase to further assess safety and preliminary antitumor activity.
Eligible participants include adults with histologically confirmed metastatic colorectal adenocarcinoma that is microsatellite stable or mismatch repair proficient and who have not received prior systemic therapy for advanced disease.
The study will evaluate safety, pharmacokinetics, immunogenicity, and preliminary efficacy outcomes including objective response rate (ORR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) based on RECIST version 1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This is a phaseII, open-label, multicenter study in previously untreated MSS/pMMR advanced colorectal cancer, evaluating JS212+Capecitabine (Cohort 1), JS212+Capecitabine+Bevacizumab (Cohort 2), JS212 + XELOX (Cohort 3) and JS212 + XELOX + JS207 (Cohort 4). Cohort 1: A dose-escalation phase (JS212 Q3W +Capecitabine) will select 1-2 RP2Ds, followed by a dose-expansion phase to assess safety, efficacy. Cohort 2: After confirming Cohort 1's RP2D, a safety lead-in phase will evaluate JS212 (RP2D) + Capecitabine + Bevacizumab Q3W. A dose-expansion phase will further assess safety, efficacy. Cohort 3: After confirming Cohort 1's RP2D, a safety lead-in phase will evaluate JS212 (RP2D) + XELOX Q3W. A dose-expansion phase will further assess safety, efficacy. Cohort 4: After confirming Cohort 1's RP2D, a safety lead-in phase will evaluate JS212 (RP2D) + XELOX + JS207 Q3W. A dose-expansion phase will further assess safety, efficacy.
| Arm | Type | Receives |
|---|---|---|
| JS212 + Capecitabine | Experimental | Drug: JS212, Drug: CapecitabineParticipants receive JS212 in combination with Capecitabine. |
| JS212 +Capecitabine+ Bevacizumab | Experimental | Drug: JS212, Drug: Capecitabine, Drug: BevacizumabParticipants receive JS212 in combination with Capecitabine and Bevacizumab |
| JS212 + XELOX | Experimental | Drug: JS212, Drug: Capecitabine, Drug: OxaliplatinParticipants receive JS212 in combination with XELOX chemotherapy (capecitabine plus oxaliplatin) |
| JS212 + XELOX + JS207 | Experimental | Drug: JS212, Drug: Capecitabine, Drug: Oxaliplatin, Drug: JS207Participants receive JS212 in combination with XELOX chemotherapy and JS207 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1Participants must meet the following key criteria
- Adults aged 18-75 years with histologically confirmed metastatic colorectal adenocarcinoma
- Microsatellite stable (MSS) or mismatch repair proficient (pMMR) disease
- No prior systemic therapy for advanced or metastatic disease
- At least one measurable lesion according to RECIST v1.1
Key exclusion criteria (9 listed)
- Participants meeting any of the following criteria will be excluded
- Prior treatment with EGFR- or HER3-targeted antibody-drug conjugates or topoisomerase I inhibitor-based ADCs
- Recent major surgery, radiotherapy, or systemic anticancer therapy prior to study treatment
- Active or uncontrolled infections or significant cardiovascular disease
- Known active central nervous system 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 |
|---|---|---|
| JS212Bispecific antibody-drug conjugate targeting EGFR and HER3 | Drug | JS212 + Capecitabine, JS212 + XELOX, JS212 + XELOX + JS207, JS212 +Capecitabine+ Bevacizumab |
| CapecitabineOral fluoropyrimidine chemotherapy | Drug | JS212 + Capecitabine, JS212 + XELOX, JS212 + XELOX + JS207, JS212 +Capecitabine+ Bevacizumab |
| BevacizumabHumanized anti-VEGF monoclonal antibody | Drug | JS212 +Capecitabine+ Bevacizumab |
| OxaliplatinPlatinum-based chemotherapy administered intravenously | Drug | JS212 + XELOX, JS212 + XELOX + JS207 |
| JS207Bispecific antibody targeting PD-1 and VEGF | Drug | JS212 + XELOX + JS207 |
Primary outcome
Investigator-assessed objective response rate (ORR)
Time frame: Up to approximately 12 months
Proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
Safety and Tolerability(AEs)
Time frame: From first dose up to approximately 90 days after last dose
Incidence and severity of adverse events (AEs) assessed according to CTCAE.
Safety and Tolerability(SAEs)
Time frame: From first dose up to approximately 90 days after last dose
Incidence and severity of serious adverse events (SAEs)assessed according to CTCAE.
Safety and Tolerability(DLTs)
Time frame: From first dose up to approximately 90 days after last dose
Incidence and severity dose-limiting toxicities (DLTs) assessed according to CTCAE.
Maximum Tolerated Dose (MTD)
Time frame: Up to approximately 6 months
Determination of MTD for JS212 combination therapy.
Recommended Phase 3 Dose (RP3D)
Time frame: Up to approximately 6 months
Determination of RP3D for JS212 combination therapy.
8 secondary outcomes
Investigator-assessed objective response rate (DCR)
Time frame: Up to approximately 12 months
Investigator-assessed Duration of Response (DoR)
Time frame: Up to approximately 12 months
Investigator-assessed Progression-Free Survival (PFS)
Time frame: Up to approximately 12 months
Investigator-assessed overall survival (OS)
Time frame: Up to approximately 20 months
PK of Cmax
Time frame: Up to approximately 12 months
PK of AUC
Time frame: Up to approximately 12 months
PK of half-time
Time frame: Up to approximately 12 months
Immunogenicity
Time frame: Up to approximately 12 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 5 May 2026.
- Individual participant dataSharing planned: No
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CRC
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.
Zhenyu Xu, Doctor study director
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JS212, Capecitabine and Bevacizumab in people with Metastatic Colorectal Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
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 10 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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 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 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?
Contact Ying Zhang, Master (86 18616904609, ying_zhang2@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed objective response rate (ORR) (time frame: Up to approximately 12 months). The study lists 6 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 5 May 2026.