Locally Advanced Colorectal CancerPhase 2NCT06846268
Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer
A Phase 2 study testing ADG126 and Pembrolizumab in people with Locally Advanced Colorectal Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This is a single site, open-label, single-arm phase II study to determine feasibility, tolerability, and preliminary efficacy of neoadjuvant ADG126 and pembrolizumab in stage II or III colorectal cancer. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Locally Advanced Colorectal Cancer
- What is being tested?
- ADG126 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Apr 2025to 31 Dec 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent for the trial.
- Be ≥ 21 years of age on the date of signing informed consent.
- ECOG performance status of 0 or 1.
- Histologically confirmed colorectal adenocarcinoma. Rectal cancers allowed if the treatment plan was upfront surgery with no need for any neoadjuvant chemotherapy or radiation.
- Clinical stage II (T3-4, N-) or stage III (Tany, N+).
- No evidence of distant metastases.
Show all 24Show fewer
- Radiologically measurable or clinically evaluable disease.
- Negative pregnancy test done 72 hours before registration, for women of childbearing potential.
- Subjects of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormone contraceptives, or double barrier method (diaphragm plus condom). Contraception, for the course of the study starting with the first dose of study medication through 150 days after the last dose of study medication. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Non-childbearing potential is defined as follows:
- ≥45 years of age and has not had a menstrual period for >1 year
- Patients who have been amenorrhoeic for <2 years without a history of hysterectomy and oophorectomy must have a follicle-stimulating hormone value in the postmenopausal range upon screening evaluation
- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure; otherwise, the patient must be willing to use 2 adequate barrier methods throughout the study.
- Demonstrate adequate organ function as defined below, all screening labs should be performed within 28 days of treatment initiation.
- Haematological
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL.
- Platelets greater than or equal to 100,000/mcL.
- Haemoglobin greater than or equal to 9 g/dL.
- Renal
- Serum creatinine OR Measured or calculated creatinine clearance (by Cockcroft-Gault equation), Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN) OR creatinine clearance greater than or equal to 60 mL/min for subject with creatinine levels greater than 1.5 x ULN
- Hepatic
- Serum total bilirubin less than or equal to 1.5 x ULN OR Direct bilirubin less than or equal to ULN for subjects with total bilirubin levels greater than 1.5 x ULN.
- AST and ALT less than or equal to 2.5 x ULN.
- Coagulation · International Normalised Ratio (INR) or Prothrombin Time (PT) or Activated Partial Thromboplastin Time (aPTT). For patients not taking warfarin: INR less than or equal to 1.5 or PT less than or equal to 1.5 x ULN; and either PTT or aPTT less than or equal to 1.5 x ULN. Patients on warfarin may be included on a stable dose with a therapeutic INR less than 3.5.
Who cannot join
- Recurrent colorectal cancer.
- Prior radiation therapy, chemotherapy, immunotherapy, or surgery for colorectal cancer.
- Tumour is causing symptomatic bowel obstruction (patients who have a temporary diverting stoma are eligible).
- Other invasive malignancy ≤5 years prior to registration.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of non-physiologic dose immunosuppressive therapy within 7 days prior to first dose of trial treatment.
- Active autoimmune disease requiring systemic treatment within the past 2 years or documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents at non-physiologic doses.
Show all 18Show fewer
- Active infection requiring systemic therapy.
- Received prior therapy with an antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Experienced ≥ Grade 3 immune-related adverse event with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
- Other anticancer or experimental therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.
- Known history of Human Immunodeficiency Virus.
- Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Women who are pregnant or breastfeeding, or men expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening visit through 150 days after the last dose of study medication.
- Concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into the study. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
- Received a live vaccine within 30 days of planned start of study medication.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrolment.
- History of interstitial lung disease.
- Known hypersensitivity to ADG126 or pembrolizumab components or excipients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Wei Peng Yong, MD, +65 69082222, Wei_Peng_YONG@nuhs.edu.sg
Silvana Wijaya, MD, +65 69082222, silvana.t.wijaya@gmail.com
About this study
Official title: Phase II Trial of Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer
This is a single site, open-label, single-arm phase II study to determine feasibility, tolerability, and preliminary efficacy of neoadjuvant ADG126 and pembrolizumab in stage II or III colorectal cancer.
Read the detailed description
This clinical trial aims to enrol patients with stage II or III colorectal cancer. At least 16, and up to 20 patients will be recruited. Patients will be given two cycles of neoadjuvant immunotherapy (ADG 126 and pembrolizumab). They will be assessed for response at 4 weeks or if they develop clinical symptoms of progression. Patients will undergo surgery 2 weeks (± 1 week) after the second dose of study treatment and within 8 weeks of study enrolment.
- Conditions
- Locally Advanced Colorectal Cancer
- Being tested
- ADG126, Pembrolizumab
- Keywords
- ADG126, Pembrolizumab, Colorectal cancer, Neoadjuvant
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADG126Drug
Administered via intravenous infusion on Day 1 only (Q6W) or Day 1 and Day 22 (Q3W).
PembrolizumabDrug
Also called Keytruda
Administered via intravenous infusion on Day 1 and Day 22.
| Study group | Role | What they receive |
|---|---|---|
| ADG126 in combination with pembrolizumab | Experimental | ADG 126 will be administered with Pembrolizumab on Day 1 and Day 22 or Pembrolizumab on Day 22 alone depending on the dose level. Receives: Drug: ADG126; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Pathologic Response (MPR)
MPR is defined as less than or equal to 10% of residual viable tumour in the surgical specimen.
Measured: Up to 4 months
Secondary outcomes (4)
Rate of Pathologic Complete Response (pCR)
pCR is defined as the absence of any residual viable tumour in the surgical specimen.
Measured: Up to 4 months.
Objective Response Rate (ORR)
Determined by the investigator according to RECIST 1.1 criteria.
Measured: Up to 4 months.
Disease-free survival (DFS)
DFS is defined as the time from surgery to the first occurrence of disease relapse or death from any cause.
Measured: Up to 5 years from surgery.
Adverse Events and Serious Adverse Events
Graded using NCI CTCAE toxicity grading v5.0
Measured: From screening to 30 days after last day of study participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start14 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- A safety run-in phase will be performed before dose expansion at the designated dose level.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Adagene Inc
- Responsible party
- Sponsor
- Investigators
- Wei Peng Yong, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846268
- Sponsor's protocol ID
- CR01/01/24
- Status last verified
- Jul 2025
- First submitted
- 24 Feb 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alieva M, van Rheenen J, Broekman MLD. Potential impact of invasive surgical procedures on primary tumor growth and metastasis. Clin Exp Metastasis. 2018 Apr;35(4):319-331. doi: 10.1007/s10585-018-9896-8. Epub 2018 May 4.
PubMed 29728948Andre T, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt C, Smith D, Garcia-Carbonero R, Benavides M, Gibbs P, de la Fouchardiere C, Rivera F, Elez E, Bendell J, Le DT, Yoshino T, Van Cutsem E, Yang P, Farooqui MZH, Marinello P, Diaz LA Jr; KEYNOTE-177 Investigators. Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer. N Engl J Med. 2020 Dec 3;383(23):2207-2218. doi: 10.1056/NEJMoa2017699.
PubMed 33264544Argiles G, Tabernero J, Labianca R, Hochhauser D, Salazar R, Iveson T, Laurent-Puig P, Quirke P, Yoshino T, Taieb J, Martinelli E, Arnold D; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Localised colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Oct;31(10):1291-1305. doi: 10.1016/j.annonc.2020.06.022. Epub 2020 Jul 20. No abstract available.
PubMed 32702383Blank CU, Lucas MW, Scolyer RA, van de Wiel BA, Menzies AM, Lopez-Yurda M, Hoeijmakers LL, Saw RPM, Lijnsvelt JM, Maher NG, Pulleman SM, Gonzalez M, Torres Acosta A, van Houdt WJ, Lo SN, Kuijpers AMJ, Spillane A, Klop WMC, Pennington TE, Zuur CL, Shannon KF, Seinstra BA, Rawson RV, Haanen JBAG, Ch'ng S, Naipal KAT, Stretch J, van Thienen JV, Rtshiladze MA, Wilgenhof S, Kapoor R, Meerveld-Eggink A, Grijpink-Ongering LG, van Akkooi ACJ, Reijers ILM, Gyorki DE, Grunhagen DJ, Speetjens FM, Vliek SB, Placzke J, Spain L, Stassen RC, Amini-Adle M, Lebbe C, Faries MB, Robert C, Ascierto PA, van Rijn R, van den Berkmortel FWPJ, Piersma D, van der Westhuizen A, Vreugdenhil G, Aarts MJB, Stevense-den Boer MAM, Atkinson V, Khattak M, Andrews MC, van den Eertwegh AJM, Boers-Sonderen MJ, Hospers GAP, Carlino MS, de Groot JB, Kapiteijn E, Suijkerbuijk KPM, Rutkowski P, Sandhu S, van der Veldt AAM, Long GV. Neoadjuvant Nivolumab and Ipilimumab in Resectable Stage III Melanoma. N Engl J Med. 2024 Nov 7;391(18):1696-1708. doi: 10.1056/NEJMoa2402604. Epub 2024 Jun 2.
PubMed 38828984Cercek A, Lumish M, Sinopoli J, Weiss J, Shia J, Lamendola-Essel M, El Dika IH, Segal N, Shcherba M, Sugarman R, Stadler Z, Yaeger R, Smith JJ, Rousseau B, Argiles G, Patel M, Desai A, Saltz LB, Widmar M, Iyer K, Zhang J, Gianino N, Crane C, Romesser PB, Pappou EP, Paty P, Garcia-Aguilar J, Gonen M, Gollub M, Weiser MR, Schalper KA, Diaz LA Jr. PD-1 Blockade in Mismatch Repair-Deficient, Locally Advanced Rectal Cancer. N Engl J Med. 2022 Jun 23;386(25):2363-2376. doi: 10.1056/NEJMoa2201445. Epub 2022 Jun 5.
PubMed 35660797Morton D, Seymour M, Magill L, Handley K, Glasbey J, Glimelius B, Palmer A, Seligmann J, Laurberg S, Murakami K, West N, Quirke P, Gray R; FOxTROT Collaborative Group. Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial. J Clin Oncol. 2023 Mar 10;41(8):1541-1552. doi: 10.1200/JCO.22.00046. Epub 2023 Jan 19.
PubMed 36657089
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
- Phase II Trial of Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06846268
- Acronym / sponsor ID
- CR01/01/24
- Conditions
- Locally Advanced Colorectal Cancer
- Keywords
- ADG126, Pembrolizumab, Colorectal cancer, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Adagene Inc
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Feb 2025 (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 single site, open-label, single-arm phase II study to determine feasibility, tolerability, and preliminary efficacy of neoadjuvant ADG126 and pembrolizumab in stage II or III colorectal cancer.
Detailed description
This clinical trial aims to enrol patients with stage II or III colorectal cancer. At least 16, and up to 20 patients will be recruited. Patients will be given two cycles of neoadjuvant immunotherapy (ADG 126 and pembrolizumab). They will be assessed for response at 4 weeks or if they develop clinical symptoms of progression. Patients will undergo surgery 2 weeks (± 1 week) after the second dose of study treatment and within 8 weeks of study enrolment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A safety run-in phase will be performed before dose expansion at the designated dose level.
| Arm | Type | Receives |
|---|---|---|
| ADG126 in combination with pembrolizumab | Experimental | Drug: ADG126, Drug: PembrolizumabADG 126 will be administered with Pembrolizumab on Day 1 and Day 22 or Pembrolizumab on Day 22 alone depending on the dose level. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Willing and able to provide written informed consent for the trial.
- Be ≥ 21 years of age on the date of signing informed consent.
- ECOG performance status of 0 or 1.
- Histologically confirmed colorectal adenocarcinoma. Rectal cancers allowed if the treatment plan was upfront surgery with no need for any neoadjuvant chemotherapy or radiation.
- Clinical stage II (T3-4, N-) or stage III (Tany, N+).
Key exclusion criteria (18 listed)
- Recurrent colorectal cancer.
- Prior radiation therapy, chemotherapy, immunotherapy, or surgery for colorectal cancer.
- Tumour is causing symptomatic bowel obstruction (patients who have a temporary diverting stoma are eligible).
- Other invasive malignancy ≤5 years prior to registration.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of non-physiologic dose immunosuppressive therapy within 7 days prior to first dose of trial treatment.
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 |
|---|---|---|
| ADG126Administered via intravenous infusion on Day 1 only (Q6W) or Day 1 and Day 22 (Q3W). | Drug | ADG126 in combination with pembrolizumab |
| PembrolizumabAlso: KeytrudaAdministered via intravenous infusion on Day 1 and Day 22. | Drug | ADG126 in combination with pembrolizumab |
Primary outcome
Rate of Major Pathologic Response (MPR)
Time frame: Up to 4 months
MPR is defined as less than or equal to 10% of residual viable tumour in the surgical specimen.
4 secondary outcomes
Rate of Pathologic Complete Response (pCR)
Time frame: Up to 4 months.
Objective Response Rate (ORR)
Time frame: Up to 4 months.
Disease-free survival (DFS)
Time frame: Up to 5 years from surgery.
Adverse Events and Serious Adverse Events
Time frame: From screening to 30 days after last day of study participation.
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.
- Background: PubMed 29728948Alieva M, van Rheenen J, Broekman MLD. Potential impact of invasive surgical procedures on primary tumor growth and metastasis. Clin Exp Metastasis. 2018 Apr;35(4):319-331. doi: 10.1007/s10585-018-9896-8. Epub 2018 May 4.
- Background: PubMed 33264544Andre T, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt C, Smith D, Garcia-Carbonero R, Benavides M, Gibbs P, de la Fouchardiere C, Rivera F, Elez E, Bendell J, Le DT, Yoshino T, Van Cutsem E, Yang P, Farooqui MZH, Marinello P, Diaz LA Jr; KEYNOTE-177 Investigators. Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer. N Engl J Med. 2020 Dec 3;383(23):2207-2218. doi: 10.1056/NEJMoa2017699.
- Background: PubMed 32702383Argiles G, Tabernero J, Labianca R, Hochhauser D, Salazar R, Iveson T, Laurent-Puig P, Quirke P, Yoshino T, Taieb J, Martinelli E, Arnold D; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Localised colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Oct;31(10):1291-1305. doi: 10.1016/j.annonc.2020.06.022. Epub 2020 Jul 20. No abstract available.
- Background: PubMed 38828984Blank CU, Lucas MW, Scolyer RA, van de Wiel BA, Menzies AM, Lopez-Yurda M, Hoeijmakers LL, Saw RPM, Lijnsvelt JM, Maher NG, Pulleman SM, Gonzalez M, Torres Acosta A, van Houdt WJ, Lo SN, Kuijpers AMJ, Spillane A, Klop WMC, Pennington TE, Zuur CL, Shannon KF, Seinstra BA, Rawson RV, Haanen JBAG, Ch'ng S, Naipal KAT, Stretch J, van Thienen JV, Rtshiladze MA, Wilgenhof S, Kapoor R, Meerveld-Eggink A, Grijpink-Ongering LG, van Akkooi ACJ, Reijers ILM, Gyorki DE, Grunhagen DJ, Speetjens FM, Vliek SB, Placzke J, Spain L, Stassen RC, Amini-Adle M, Lebbe C, Faries MB, Robert C, Ascierto PA, van Rijn R, van den Berkmortel FWPJ, Piersma D, van der Westhuizen A, Vreugdenhil G, Aarts MJB, Stevense-den Boer MAM, Atkinson V, Khattak M, Andrews MC, van den Eertwegh AJM, Boers-Sonderen MJ, Hospers GAP, Carlino MS, de Groot JB, Kapiteijn E, Suijkerbuijk KPM, Rutkowski P, Sandhu S, van der Veldt AAM, Long GV. Neoadjuvant Nivolumab and Ipilimumab in Resectable Stage III Melanoma. N Engl J Med. 2024 Nov 7;391(18):1696-1708. doi: 10.1056/NEJMoa2402604. Epub 2024 Jun 2.
- Background: PubMed 35660797Cercek A, Lumish M, Sinopoli J, Weiss J, Shia J, Lamendola-Essel M, El Dika IH, Segal N, Shcherba M, Sugarman R, Stadler Z, Yaeger R, Smith JJ, Rousseau B, Argiles G, Patel M, Desai A, Saltz LB, Widmar M, Iyer K, Zhang J, Gianino N, Crane C, Romesser PB, Pappou EP, Paty P, Garcia-Aguilar J, Gonen M, Gollub M, Weiser MR, Schalper KA, Diaz LA Jr. PD-1 Blockade in Mismatch Repair-Deficient, Locally Advanced Rectal Cancer. N Engl J Med. 2022 Jun 23;386(25):2363-2376. doi: 10.1056/NEJMoa2201445. Epub 2022 Jun 5.
- Background: PubMed 36657089Morton D, Seymour M, Magill L, Handley K, Glasbey J, Glimelius B, Palmer A, Seligmann J, Laurberg S, Murakami K, West N, Quirke P, Gray R; FOxTROT Collaborative Group. Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial. J Clin Oncol. 2023 Mar 10;41(8):1541-1552. doi: 10.1200/JCO.22.00046. Epub 2023 Jan 19.
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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.
Wei Peng Yong, MD 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 2 study testing ADG126 and Pembrolizumab in people with Locally Advanced Colorectal 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 24 inclusion and 18 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 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 Wei Peng Yong, MD (+65 69082222, Wei_Peng_YONG@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major Pathologic Response (MPR) (time frame: Up to 4 months). 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 NCT06846268, which also lists 6 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; AzTrials last refreshed its copy on 8 Nov 2026.