BridgeMD
New treatment option for Locally Advanced Colorectal Cancer
Official title Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer
ClinicalTrials.gov ID: NCT06846268
What this study is testing
What is ADG126?
ADG126 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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...
- Clinical stage II (T3-4, N-) or stage III (Tany, N+).
You likely can't join if
- 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...
- Active autoimmune disease requiring systemic treatment within the past 2 years or documented history of clinically severe autoimmune disease, or a...
See the full eligibility criteria
- 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.
- Radiologically measurable or clinically evaluable disease.
- Negative pregnancy test done 72 hours before registration, for women of childbearing potential. people of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth...
- ≥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...
- 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...
- Hepatic
- Serum total bilirubin less than or equal to 1.5 x ULN OR Direct bilirubin less than or equal to ULN for people 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.