Advanced Solid TumorPhase 1/2ComPACTNCT05491083
Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer
A Phase 1/2 study testing Pembrolizumab & ADG106 (Phase Ib) and Pembrolizumab & ADG106 (Phase II) in people with Advanced Solid Tumor and Triple Negative Breast Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This is a phase Ib followed by phase II clinical trial evaluating the safety and efficacy of combination of ADG106 with pembrolizumab in patients with metastatic cancers. The Phase Ib dose finding part will include all solid tumor subtypes with treatment refractory disease, while phase II will focus on only patients… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Advanced Solid Tumor, Triple Negative Breast Cancer
- What is being tested?
- Pembrolizumab & ADG106 (Phase Ib) and Pembrolizumab & ADG106 (Phase II)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Jun 2023to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years and above of age
- Estimated life expectancy of at least 12 weeks.
- Has recovered from acute toxicities from prior anti-cancer therapies.
- Has a tumor lesion that can be safely biopsied and who is willing to undergo tumor biopsy at baseline before starting study treatment
- Phase Ib
- Patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have radiological evidence of progressive disease on study entry
Show all 28Show fewer
- There is no upper limit on the number of prior treatments provided all inclusion/ exclusion criteria are met.
- Prior treatment with immunotherapy is allowed.
- Phase II
- Patients with histologically or cytologically confirmed TNBC, defined by expression of estrogen (ER) and progesterone receptors (PR) of <1% and HER2 IHC score of 0 or 1+ or HER2 IHC score of 2+ but HER2 FISH negative.
- Received at least 1 line but no more than 2 prior lines of systemic therapy in the metastatic setting, including chemotherapy or targeted therapy (e.g., PARP inhibitors).
- Tumor CPS≥1 determined by the DAKO 22C3 assay assessed by local or central laboratory.
- Measurable disease by RECIST 1.1 criteria as determined by local radiological review. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Adequate bone marrow function and organ function within 2 weeks of study treatment.
- Adequate hematologic function defined as:
- Absolute neutrophil count (ANC) - 1.5 x 109/L
- Platelets - 100 x 109/L
- Hemoglobin - 9 x 109/L
- Adequate hepatic function defined as:
- Bilirubin ≤1.5 times the upper limit of normal (ULN)
- ALT or AST ≤ 2.5 times ULN (or ≤5 times ULN with presence of liver metastases)
- Adequate renal function defined as:
- Calculated creatinine clearance of ≥ 60 mL/min, calculated using the formula of Cockroft and Gault: (140-Age) x Mass (kg)/(72 x creatinine mg/dL); multiply by 0.85 if female.
- Adequate coagulation function as defined by:
- International normalised ratio (INR) OR prothrombin time (PT)/activated partial thromboplastin time (aPTT) ≤1.5x ULN unless participant is receiving anticoagulant therapy, for which it will be acceptable as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
- Patients with reproductive potential must use an approved contraceptive method as detailed in appendix A of the protocol during the period and for at least 120 days (corresponding to 5 terminal half-lives for pembrolizumab therapy) plus 30 days (corresponding to a menstruation cycle) for female, and for at least 120 days plus 90 days (corresponding to a spermatogenesis cycle) for male patients. In addition, females with childbearing potential must have a negative serum pregnancy test within 72 hours prior to study enrolment.
- Have signed informed consent in accordance with local institutional guidelines, and able to comply with scheduled visits, treatment plan and study related procedures.
Who cannot join
- Patients will be excluded from the study for any of the following reasons:
- Treatment within the last 30 days with any investigational drug. Participants must have recovered from all adverse events due to previous therapies to ≤grade 1 or baseline. Participants with ≤grade 2 neuropathy may be eligible. Participants with endocrine related AEs of ≤grade 2 requiring treatment or hormone replacement may be eligible.
- Prior treatment with immune checkpoint inhibitor in phase II; prior immune checkpoint inhibitors are allowed for phase Ib
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy
- Major surgery within 28 days of study drug administration
- Prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids for radiotherapy-related adverse events, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation lasting ≤2 weeks to a non-CNS site.
Show all 23Show fewer
- Active infection that requires systemic therapy, and that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Has severe hypersensitivity (≥grade 3) to pembrolizumab and/or any of its excipients.
- Active, known or suspected autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency etc.) is not considered a form of systemic treatment and is allowed.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrolment. Inhaled or topical steroids, and adrenal replacement steroid >10mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to first dose of study drug. Administration of killed vaccines is allowed.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Active hepatitis B (defined as viral load ≥1000 copies/ml) or HCV (hepatitis C virus) [positive HCV RNA])
- Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible. Patients who are known HBV carriers on anti-viral therapy with a viral load of <1000 copies may be enrolled. HBV DNA must be obtained in these patients prior to enrolment.
- Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrolment. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast or cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
- History of significant neurological or mental disorder, including seizures or dementia.
- History of allogenic tissue or solid organ transplant.
- Unable to comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Soo Chin Lee contact
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
Soo Chin Lee, +65 6908 2222, soo_chin_lee@nuhs.edu.sg
Soo Chin Lee
About this study
Official title: A Phase 1b Followed by Phase II Expansion Trial of Combination of Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer (ComPACT)
This is a phase Ib followed by phase II clinical trial evaluating the safety and efficacy of combination of ADG106 with pembrolizumab in patients with metastatic cancers. The Phase Ib dose finding part will include all solid tumor subtypes with treatment refractory disease, while phase II will focus on only patients with TNBC.
Read the detailed description
2.1 Hypothesis
- Combination of ADG106 and pembrolizumab is safe with a reasonable toxicity profile.
- Combination of ADG106 and pembrolizumab is effective and can improve outcomes in patients with advanced TNBC.
- Predictive biomarkers may help select patients most likely to benefit from combination therapy.
2.2 Primary Objectives Phase Ib
- Evaluate the safety and tolerability of combination of ADG106 with pembrolizumab in patients with advanced solid tumors.
- Determine recommended phase II dose (RP2D) of ADG106 in combination with pembrolizumab.
Phase II • Evaluate the clinical efficacy of ADG106 plus pembrolizumab in terms of ORR in patient with advanced TNBC with CPS ≥1
2.3 Secondary Objectives Phase Ib
- Evaluate preliminary anti-tumor effect of combination of ADG106 with pembrolizumab in terms of ORR, disease control rate (DCR), PFS and OS in patients with treatment refractory solid tumors
Phase II
- Evaluate clinical efficacy of ADG106 plus pembrolizumab in terms of DCR, PFS and OS in patients with advanced TNBC with CPS≥1
- Evaluate clinical efficacy of ADG106 plus pembrolizumab in terms of ORR, DCR, PFS and OS in patients with advanced TNBC with CPS≥10
2.4 Exploratory Objectives
- Evaluate predictive biomarkers (e.g., tumor PD-L1 CPS score) for response to ADG106 plus pembrolizumab.
- Evaluate changes in tumor microenvironment with combination of ADG106 plus pembrolizumab.
- Evaluate changes in tumor genomic expression profile with combination of ADG106 plus pembrolizumab.
- Being tested
- Pembrolizumab & ADG106 (Phase Ib), Pembrolizumab & ADG106 (Phase II)
- Keywords
- Pembrolizumab, ADG106, Breast Cancer, Triple Negative
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab & ADG106 (Phase Ib)Drug
Drug: ADG106
Administered as an intravenous infusion over 60-90 minutes in the initial cycle and over 30 minutes in subsequent cycle if well tolerated.
Pembrolizumab
Administered as an intravenous infusion over 30 minutes
Pembrolizumab & ADG106 (Phase II)Drug
Drug: ADG106
Administered as an intravenous infusion over 60-90 minutes in the initial cycle and over 30 minutes in subsequent cycle if well tolerated.
Pembrolizumab
Administered as an intravenous infusion over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b Pembrolizumab & ADG106 | Experimental | Intravenous Pembrolizumab + ADG106 on day 1 of each 3-weekly cycle Receives: Drug: Pembrolizumab & ADG106 (Phase Ib) |
| Phase 2 Pembrolizumab & ADG106 | Experimental | Intravenous Pembrolizumab + ADG106 each 3-weekly cycle Receives: Drug: Pembrolizumab & ADG106 (Phase II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participant with treatment related toxicities (Phase Ib)
Toxicities will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading Version 5
Measured: 3 years
Objective response rate (ORR) in Phase II
Complete and partial clinical response will be measured by RECIST 1.1.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start12 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- * Phase Ib: Patients with advanced solid tumors will be enrolled in a 3+3 dose escalation fashion, with projected enrolment of between 6-18 patients to determine RP2D. Once the RP2D is confirmed, the study will proceed to phase II. * Phase II: Up to a total of 33 patients with advanced triple negative breast cancer will be enrolled.
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Adagene Inc, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Soo Chin Lee, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491083
- Sponsor's protocol ID
- BR01/01/22
- Acronym
- ComPACT
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caswell-Jin JL, Plevritis SK, Tian L, Cadham CJ, Xu C, Stout NK, Sledge GW, Mandelblatt JS, Kurian AW. Change in Survival in Metastatic Breast Cancer with Treatment Advances: Meta-Analysis and Systematic Review. JNCI Cancer Spectr. 2018 Nov;2(4):pky062. doi: 10.1093/jncics/pky062. Epub 2018 Dec 24.
PubMed 30627694Skinner KE, Haiderali A, Huang M, Schwartzberg LS. Real-world effectiveness outcomes in patients diagnosed with metastatic triple-negative breast cancer. Future Oncol. 2021 Mar;17(8):931-941. doi: 10.2217/fon-2020-1021. Epub 2020 Nov 19.
PubMed 33207944Fossati R, Confalonieri C, Torri V, Ghislandi E, Penna A, Pistotti V, Tinazzi A, Liberati A. Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women. J Clin Oncol. 1998 Oct;16(10):3439-60. doi: 10.1200/JCO.1998.16.10.3439.
PubMed 9779724
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Followed by Phase II Expansion Trial of Combination of Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer (ComPACT)
- ClinicalTrials.gov ID
- NCT05491083
- Acronym / sponsor ID
- ComPACT / BR01/01/22
- Keywords
- Pembrolizumab, ADG106, Breast Cancer, Triple Negative
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Adagene Inc, Merck Sharp & Dohme LLC
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Aug 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.
This is a phase Ib followed by phase II clinical trial evaluating the safety and efficacy of combination of ADG106 with pembrolizumab in patients with metastatic cancers. The Phase Ib dose finding part will include all solid tumor subtypes with treatment refractory disease, while phase II will focus on only patients with TNBC.
Detailed description
2.1 Hypothesis
- Combination of ADG106 and pembrolizumab is safe with a reasonable toxicity profile.
- Combination of ADG106 and pembrolizumab is effective and can improve outcomes in patients with advanced TNBC.
- Predictive biomarkers may help select patients most likely to benefit from combination therapy.
2.2 Primary Objectives Phase Ib
- Evaluate the safety and tolerability of combination of ADG106 with pembrolizumab in patients with advanced solid tumors.
- Determine recommended phase II dose (RP2D) of ADG106 in combination with pembrolizumab.
Phase II • Evaluate the clinical efficacy of ADG106 plus pembrolizumab in terms of ORR in patient with advanced TNBC with CPS ≥1
2.3 Secondary Objectives Phase Ib
- Evaluate preliminary anti-tumor effect of combination of ADG106 with pembrolizumab in terms of ORR, disease control rate (DCR), PFS and OS in patients with treatment refractory solid tumors
Phase II
- Evaluate clinical efficacy of ADG106 plus pembrolizumab in terms of DCR, PFS and OS in patients with advanced TNBC with CPS≥1
- Evaluate clinical efficacy of ADG106 plus pembrolizumab in terms of ORR, DCR, PFS and OS in patients with advanced TNBC with CPS≥10
2.4 Exploratory Objectives
- Evaluate predictive biomarkers (e.g., tumor PD-L1 CPS score) for response to ADG106 plus pembrolizumab.
- Evaluate changes in tumor microenvironment with combination of ADG106 plus pembrolizumab.
- Evaluate changes in tumor genomic expression profile with combination of ADG106 plus pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Phase Ib: Patients with advanced solid tumors will be enrolled in a 3+3 dose escalation fashion, with projected enrolment of between 6-18 patients to determine RP2D. Once the RP2D is confirmed, the study will proceed to phase II. * Phase II: Up to a total of 33 patients with advanced triple negative breast cancer will be enrolled.
| Arm | Type | Receives |
|---|---|---|
| Phase 1b Pembrolizumab & ADG106 | Experimental | Drug: Pembrolizumab & ADG106 (Phase Ib)Intravenous Pembrolizumab + ADG106 on day 1 of each 3-weekly cycle |
| Phase 2 Pembrolizumab & ADG106 | Experimental | Drug: Pembrolizumab & ADG106 (Phase II)Intravenous Pembrolizumab + ADG106 each 3-weekly cycle |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 21 years and above of age
- Estimated life expectancy of at least 12 weeks.
- Has recovered from acute toxicities from prior anti-cancer therapies.
- Has a tumor lesion that can be safely biopsied and who is willing to undergo tumor biopsy at baseline before starting study treatment
- Phase Ib
Key exclusion criteria (23 listed)
- Patients will be excluded from the study for any of the following reasons:
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 |
|---|---|---|
| Pembrolizumab & ADG106 (Phase Ib)Drug: ADG106 Administered as an intravenous infusion over 60-90 minutes in the initial cycle and over 30 minutes in subsequent cycle if well tolerated. Pembrolizumab Administered as an intravenous infusion over 30 minutes | Drug | Phase 1b Pembrolizumab & ADG106 |
| Pembrolizumab & ADG106 (Phase II)Drug: ADG106 Administered as an intravenous infusion over 60-90 minutes in the initial cycle and over 30 minutes in subsequent cycle if well tolerated. Pembrolizumab Administered as an intravenous infusion over 30 minutes | Drug | Phase 2 Pembrolizumab & ADG106 |
Primary outcome
Number of participant with treatment related toxicities (Phase Ib)
Time frame: 3 years
Toxicities will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading Version 5
Objective response rate (ORR) in Phase II
Time frame: 3 years
Complete and partial clinical response will be measured by RECIST 1.1.
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 25 Jul 2025.
- Results publication: PubMed 30627694Caswell-Jin JL, Plevritis SK, Tian L, Cadham CJ, Xu C, Stout NK, Sledge GW, Mandelblatt JS, Kurian AW. Change in Survival in Metastatic Breast Cancer with Treatment Advances: Meta-Analysis and Systematic Review. JNCI Cancer Spectr. 2018 Nov;2(4):pky062. doi: 10.1093/jncics/pky062. Epub 2018 Dec 24.
- Results publication: PubMed 33207944Skinner KE, Haiderali A, Huang M, Schwartzberg LS. Real-world effectiveness outcomes in patients diagnosed with metastatic triple-negative breast cancer. Future Oncol. 2021 Mar;17(8):931-941. doi: 10.2217/fon-2020-1021. Epub 2020 Nov 19.
- Results publication: PubMed 9779724Fossati R, Confalonieri C, Torri V, Ghislandi E, Penna A, Pistotti V, Tinazzi A, Liberati A. Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women. J Clin Oncol. 1998 Oct;16(10):3439-60. doi: 10.1200/JCO.1998.16.10.3439.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Soo Chin Lee contact
Soo Chin Lee principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pembrolizumab & ADG106 (Phase Ib) and Pembrolizumab & ADG106 (Phase II) in people with Advanced Solid Tumor and Triple Negative Breast Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
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 28 inclusion and 23 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 25 Jul 2025. 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 Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soo Chin Lee (+65 6908 2222, soo_chin_lee@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participant with treatment related toxicities (Phase Ib) (time frame: 3 years). 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?
On the ClinicalTrials.gov record for NCT05491083, which also lists 3 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 25 Jul 2025.