Advanced Solid Tumors study: CBX-663
Official title A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-663 in Participants With Relapsed or Refractory Myeloid Malignancies, Advanced Solid Tumors, or Recurrent or Progressive Glioblastoma.
ClinicalTrials.gov ID: NCT07779798
What this study is testing
What is CBX-663?
CBX-663 is an investigational medicine being studied as a potential treatment for advanced solid tumors.
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 study is testing how safe the drug is and what side effects it causes. It also looks at how well the drug works.
- Who it's for
- You may be able to join if you are 18 or older and have a specific type of cancer.
- What's involved
- You would get the drug through a vein in your arm. You would get it once a week for three weeks, then take a break.
- Time commitment
- You would keep getting the drug until it stops working or causes too many side effects.
- Phase 1: an early, usually small safety 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 and older
You may be able to join if
- Cohort A (R/R AML, MDS or CMML) Specific
- R/R AML, as defined by standardized criteria (e.g., European Leukemia Net criteria (Dohner, 2022) (Arber, 2022); after standard of care therapy.
- R/R MDS as per WHO 2022. Participants must have peripheral or bone marrow blasts \<20%, and must have exhausted locally available treatments...
- R/R dysplastic or proliferative CMML participants, participants must be resistant or refractory to 4-6 cycles of hypomethylating agents (HMA
- White blood cells must be below 25,000/µL at time of enrollment. Participants may receive cytoreduction prior to enrollment.
You likely can't join if
- Known or suspected leptomeningeal disease are excluded, defined as radiographic evidence of leptomeningeal involvement on MRI of the brain and/or...
- Tumors involving the brainstem or spinal cord are excluded, including primary tumors arising from, or metastatic lesions involving, the brainstem...
- Received prior bevacizumab or any other anti-VEGF or anti-VEGFR therapy.
- Absolute lymphocyte count \<800/uL.
- Previous treatment with any pHLA-targeting T-cell engager.
- Isolated extramedullary relapse.
See the full eligibility criteria
Who can join
- Cohort A (R/R AML, MDS or CMML) Specific
- R/R AML, as defined by standardized criteria (e.g., European Leukemia Net criteria (Dohner, 2022) (Arber, 2022); after standard of care therapy.
- R/R MDS as per WHO 2022. Participants must have peripheral or bone marrow blasts \<20%, and must have exhausted locally available treatments, including treatments for actionable mutations. a.
- R/R dysplastic or proliferative CMML participants, participants must be resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).
- White blood cells must be below 25,000/µL at time of enrollment. Participants may receive cytoreduction prior to enrollment.
- Any prior treatment-related toxicities resolved to Grade ≤1 prior to enrollment, with the exception of Grade ≤2 alopecia. Cohort B (Solid Tumor) Specific
- Histologically or cytologically diagnosed, locally advanced (unresectable) or metastatic solid cancers that have progressed after all available standard therapy for the specific tumor type, or for which no standard...
- Measurable disease (as defined by RECIST version 1.1). Prior Therapy
- Any prior treatment-related toxicities resolved to Grade ≤1 prior to enrollment, with the exception of Grade ≤2 alopecia.
- Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily) or cytoreductive therapy.
- Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors.
- Anti-Cancer Therapy: Chemotherapy or small molecule targeted therapy, either investigational or commercially approved and available, within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of study drug...
- Radiation Therapy: At least 60 days from prior total body irradiation, craniospinal radiation and/or ≥50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port).
- Histologically confirmed or molecularly defined diagnosis of glioblastoma (IDH-wildtype) according to WHO 2021.
- Historical documented evidence of a TERT promoter mutation.
- Radiographic evidence of recurrent or progressive disease following prior first-line radiotherapy, defined as progression per RANO 2.0 criteria, as determined by investigator assessment.
- Measurable (at least 1 cm x 1 cm) enhancing tumor.
- Aged ≥18 years.
- Backfill Cohorts: Participants for whom no curative treatment options, including transplantation, are available.
- Historical documented evidence of HLA-A\ 02:01 allele positivity.
- ECOG PS score 0-1. Adequate Organ Function Requirements within 10 Days of Treatment Initiation
- Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 based on local institutional practice (e.g., Cockcroft-Gault formula).
- Total bilirubin \<1.5 × the upper limit of normal (ULN) for age or normal conjugated bilirubin, or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in participants with well documented Gilbert's...
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<3 × ULN (unless attributed to leukemic or tumor involvement with discussion with the Study Responsible Physician).
- If a female of childbearing potential, willing to use a highly effective method of contraception or double barrier method from the time of enrollment through 120 days following the last study drug dose.
- If male of childbearing potential, agrees to use barrier contraception from the time of enrollment through 120 days following the last study drug dose.
- Participant or participant's health care proxy is able and willing to provide written informed consent and able to follow study instructions.
What rules you out
- Known or suspected leptomeningeal disease are excluded, defined as radiographic evidence of leptomeningeal involvement on MRI of the brain and/or spine, or positive cerebrospinal fluid (CSF) cytology, at screening or...
- Tumors involving the brainstem or spinal cord are excluded, including primary tumors arising from, or metastatic lesions involving, the brainstem (midbrain, pons, or medulla) or spinal cord.
- Received prior bevacizumab or any other anti-VEGF or anti-VEGFR therapy.
- Absolute lymphocyte count \<800/uL.
- Previous treatment with any pHLA-targeting T-cell engager.
- Isolated extramedullary relapse.
- Active central nervous system (CNS) disease. Participants with prior CNS history can be enrolled if the participant has a negative lumbar puncture following completion of intrathecal chemotherapy.
- Note: this does not apply to Cohort C GBM participants
- Known HIV infection.
- Active hepatitis B infection (participants with documented clearance following treatment are allowed).
- Active hepatitis C infection (participants with documented clearance following treatment are allowed).
- Any acute or chronic infection requiring systemic treatment
- Pregnant or nursing women: Negative serum pregnancy tests are required during Screening and a negative serum or urine pregnancy test is required within 72 hours prior to receiving the first study drug administration, in...
- Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class \>II), life-threatening...
- QTc using Fridericia's correction (QTcF) \>480 msec
- Graft-Versus-Host Disease (GVHD): Active GVHD.
- Concurrent malignancy in the previous 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ, melanoma...
- Current or historical diagnosis of a gastrointestinal autoimmune or inflammatory condition, including but not limited to ulcerative colitis (UC), Crohn's disease (CD), indeterminate colitis, or microscopic colitis...
- Significant impairment of lung function requiring chronic use of ambulatory supplemental oxygen.
- Screening laboratory values or investigations that do not meet the requirements for adequate organ function.
- History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the participant's participation for the full duration...
- Intrathecal chemotherapy for CNS prophylaxis is permitted after C1 is complete, at the treating physician's discretion.
- Participants who experienced severe, life-threatening or recurrent (≥ Grade 2) immune-mediated adverse events or infusion-related reactions including those that led to permanent discontinuation while on previous...
- Any concurrent systemic treatment to prevent GVHD. Topical treatments for GVHD are permitted. Participants who stopped calcineurin inhibitor (CNI) prophylaxis should be off CNI for at least 4 weeks.
- Known allergy or sensitivity to study drug, including excipients.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Tampa, Florida, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Tampa, Florida, United States; Houston, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.