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. (NCT07779798)

🧪 Interventions in This Study

• CBX-663 (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Cohort A (R/R AML, MDS or CMML) Specific Inclusion Criteria:
2. R/R AML, as defined by standardized criteria (e.g., European Leukemia Net criteria (Dohner, 2022) (Arber, 2022); after standard of care therapy. Participants with persistent leukemia after initial therapy or with recurrence of leukemia at any time after achieving a response during or after the course of treatment (including HSCT) are eligible. Participants must have bone marrow blasts ≥5%.
3. 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. For High-Risk MDS participants, participants must be resistant to or refractory to at least 4 cycles of hypomethylating agents or have progressed or are intolerant to such agents.
4. R/R dysplastic or proliferative CMML participants, participants must be resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).
5. White blood cells must be below 25,000/µL at time of enrollment. Participants may receive cytoreduction prior to enrollment.
6. Any prior treatment-related toxicities resolved to Grade ≤1 prior to enrollment, with the exception of Grade ≤2 alopecia. Cohort B (Solid Tumor) Specific Inclusion Criteria:
7. 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 therapy exists. Participants for whom standard therapies are intolerable or considered inappropriate by the Investigator are eligible.
8. Measurable disease (as defined by RECIST version 1.1). Prior Therapy
9. Any prior treatment-related toxicities resolved to Grade ≤1 prior to enrollment, with the exception of Grade ≤2 alopecia.
10. Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily) or cytoreductive therapy. Cytoreductive therapy must have approval of the Study Responsible Physician.
11. 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.
12. 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 administration.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• NEXT Oncology- Virginia — Fairfax, Virginia

📞 Contact the Study Coordinator

Phone: (703) 783-4518

Email: mdelarosa@nextoncology.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: Participants may receive cytoreduction prior to enrollment.

More studies in Advanced Solid Tumors

• A Trial to Investigate the Safety of E303 in Participants With Advanced Refractory Solid Tumors — Scottsdale, Arizona
• A Study of MGC028 in Participants With Advanced Solid Tumors — San Francisco, California
• A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001) — Tampa, Florida
• Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors — Los Angeles, California
• A Study of mRNA-4106 or mRNA-4200 Administered Alone or in Combination With Anti-Cancer Agents in Participants With Solid Tumors — Los Angeles, California

Explore by condition: All Advanced Solid Tumors clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.