Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment
Open-label Phase 2 Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "To associate clinical outcomes with PK, PD, anti-drug antibodies, and biomarkers obtained from tissue and blood samples."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well AMB-05X works for adults with colon or rectal cancer after treatment meant to cure it. It is for people with no cancer found on scans or exams, but whose blood test still shows DNA from cancer cells.
To investigate the efficacy of AMB-05X in patients with CRC with MRD as determined by a ctDNA(+) blood test and no clinically detectable radiographic disease.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and able and willing to sign a study consent form.
- Have adenocarcinoma, a type of colon or rectal cancer, confirmed by a tissue test.
- Have finished all planned treatments meant to cure stage I–IV colon or rectal cancer, with no cancer found afterward.
- Have no cancer found on scans or other standard exams at least 28 days after finishing all planned standard treatment.
- Have a positive Signatera blood test for cancer DNA at least 28 days after finishing treatment. Tests from other centers are accepted.
- Meet the study’s blood count, liver, and kidney test requirements.
- Be fully active or able to do light work despite some limits on hard physical activity.
- Follow the study’s birth control rules before treatment, during the study, and for at least 90 days after the last dose. Not having sex during this entire time is also allowed.
Who can't join
- Have another cancer within 3 years of signing up that could affect study safety or results, or needs treatment at the same time.
- Have serious liver or bile system disease, or another health condition or abnormal test result that makes treatment unsafe. This includes serious heart disease or diseases where the immune system attacks the body.
- Have ongoing hepatitis B with detectable virus in the blood. Past hepatitis C must be treated and cured; people still being treated must have no detectable virus.
- Have lasting moderate or worse side effects from past cancer treatment, except hair loss or nerve damage.
- Have had a severe allergic reaction to human or humanized monoclonal antibody treatment, a type of treatment made from immune proteins.
- Be pregnant. Breastfeeding must stop if receiving AMB-05X.
- Be receiving other cancer medicines or study drugs outside this study, or have used pexidartinib, another oral tyrosine kinase inhibitor, or a treatment targeting CSF1 or CSF1R in the past 4 weeks.
- Have a mental health condition or life situation that would make it hard to follow study requirements.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Histologic or pathologic confirmation of adenocarcinoma of the colon or rectum. 2. Completion of any curative intent therapies resulting in no evidence of disease (e.g., R0 resection) for stage I - IV CRC and has completed all planned adjuvant/standard therapies per the discretion of the evaluating clinician. 3. No evidence of measurable radiographic disease according to RECIST 1.1 criteria (Eisenhauer et al. Eur. J Cancer 2009) and/or clinically detectable disease (i.e., via endoscopy if utilized as part of standard of care assessment) at least 28 days after completion of all planned standard of care treatment. 4. A positive ctDNA assay (Signatera) at least 28 days after completion of all planned standard of care treatment. Assays performed at external institutions are accepted. 5. Adequate organ and marrow function as defined below: 1. absolute neutrophil count: ≥1,000/mcL 2. platelets: ≥75,000/mcL 3. hemoglobin: .9.0 g/dL 4. total bilirubin: ≤ institutional upper limit of normal (ULN) 5. AST(SGOT)/ALT(SGPT): ≤1.5 × institutional ULN 6. Creatinine clearance ≥50 mL/min. Creatinine clearance (CrCl) to be estimated by the Cockcroft-Gault equation as follows: Clcr (mL/min) = \[(140 - age) x (weight in kg) ÷ \[72 x (serum creatinine in mg/dL)\] \[0.85 if female\] 6. ECOG performance status (PS) of 0 or 1 (Appendix A). 7. Age ≥ 18 years at the time of informed consent for study participation. 8. Ability to understand and willingness to sign a written informed consent document. 9. The effects of AMB-05X on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 90 days after the last dose of study treatment. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: * Postmenopausal (no menses in greater than or equal to 12 consecutive months). * History of hysterectomy or bilateral salpingo-oophorectomy. * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). * History of bilateral tubal ligation or another surgical sterilization procedure. 10. Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 11. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of AMB-05X administration. Exclusion Criteria: 1. Prior or concurrent malignancy within 3 years of registration whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen or requires concurrent therapy (examples include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal carcinoma in situ, cervical carcinoma in situ). 2. Clinically significant hepatobiliary disease that, at the discretion of the treating investigator, would lead to excessive treatment risk on study. 3. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 4. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 5. Concomitant health conditions including, but not limited to, autoimmune or cardiovascular disorders that are deemed significant in the investigator's judgment. 6. Persistent adverse event greater than or equal to grade 2 of the Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0 related to prior anti-cancer therapy (with the exceptions of alopecia and neuropathy). 7. Coexisting separate disease, metabolic disorder, clinically significant laboratory result, or any other condition that investigators suspect may (a) prohibit use of the investigational product, or (b) put the patient at undue risk of harm. 8. History of a grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy 9. Pregnant women are excluded from this study because AMB-05X is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AMB-05X, breastfeeding should be discontinued if the mother is treated with AMB-05X. These potential risks may also apply to other agents used in this study 10. Concurrent treatment with other systemic anti-cancer agents (e.g., chemotherapy, hormonal therapy, immunotherapy) or other treatments not part of protocol-specified anti-cancer therapy including concurrent investigational agents of any type. 11. Use of pexidartinib, any other oral tyrosine kinase inhibitor (e.g., imatinib or nilotinib), or any biologic treatment targeting CSF1 or CSF1R within the past 4 weeks. 12. Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Study sites (1)
TX
- The University of Texas MD Anderson Cancer Center · Houston, TX 77030Van Morris, MD · Study contact · 713-792-2828 · GIClinicalTrials@mdanderson.orgVan Morris, MD · Principal investigatorMore trials in Houston