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New treatment option for Colorectal Adenocarcinoma
Official title AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06951503
What this study is testing
What is AK112?
AK112 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal adenocarcinoma.
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 trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Signed informed consent.
- Age ≥ 18 years and ≤ 75 years.
- ECOG status of 0 or 1.
- Estimated survival ≥ 3 months.
- people with histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
You likely can't join if
- Previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured.
- Participating in other treatment study within 4 weeks prior to the first study drug administration.
- Palliative local treatment for non-target lesions within 2 weeks prior to the first administration; received non-specific immunomodulatory therapy...
- Current presence of uncontrolled combined disease.
- Active clinical infections.
- History of severe bleeding tendency or coagulation dysfunction.
See the full eligibility criteria
- Signed informed consent.
- Age ≥ 18 years and ≤ 75 years.
- ECOG status of 0 or 1.
- Estimated survival ≥ 3 months.
- people with histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
- people who are not candidates for radical surgical resection or local therapy and have not received systemic anti-tumor therapy in the recurrent or metastatic setting. people who have received prior neoadjuvant or...
- At least one measurable disease based on RECIST v1.1.
- Adequate organ function per protocol-defined criteria.
- Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 180 days following the last dose of study treatment.
- Previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured.
- Participating in other treatment study within 4 weeks prior to the first study drug administration.
- Palliative local treatment for non-target lesions within 2 weeks prior to the first administration; received non-specific immunomodulatory therapy within 2 weeks prior to the first administration.
- Current presence of uncontrolled combined disease.
- Active clinical infections.
- History of severe bleeding tendency or coagulation dysfunction.
- people with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection.
- Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study.
- Current presence of significant radiographic or clinical manifestations of GI obstruction.
- Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
- Pregnant or lactating women.
- Any condition considered by the investigator to be inappropriate for enrollment.
- Local or systemic disease caused by non-malignancy, or disease or symptom secondary to tumor, that can lead to higher medical risk and/or uncertainty in survival.
The study team makes the final eligibility decision.
Where it's taking place
- Guanzhou, Guangdong, China
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guanzhou, Guangdong, China. 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.