A Phase 1b Study of Gemcitabine and Nab-paclitaxel in Combination With IM156 in Patients With Advanced Pancreatic Cancer. (NCT05497778)

🧪 Interventions in This Study

• Gemcitabine (DRUG)
• Nab paclitaxel (DRUG)
• IM156 (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. For inclusion in the study patients must fulfill all the following criteria:
2. Ability to understand and the willingness to sign a written informed consent form (ICF).
3. Male or female participants ≥ 18 years of age at the time of screening. Because no dosing or adverse event data are currently available on the use of IM156 in combination with Gem + NP in patients \<18 years of age, children are excluded from this study.
4. Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.
5. Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria \[13\], defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. The measurable lesion must be outside of a radiation field if the participant received prior radiation.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see Appendix 1).
7. Naïve to any prior treatment for metastatic disease, including chemotherapy, biological therapy, or targeted therapy.
8. Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if neoadjuvant or adjuvant therapy was completed at least 6 months prior to study enrollment. Prior adjuvant therapy may include Gem or NP.
9. Participants initially diagnosed with localized pancreatic cancer who have undergone chemotherapy then resection and had no evidence of disease are eligible if relapse of metastatic disease has occurred and if the last dose of chemotherapy was received more than 6 months before study entry.
10. Prior radiation therapy must have been completed at least 14 days before investigational product administration.
11. Prior surgery that required general anesthesia or other major surgery as defined by the investigator must be completed at least 4 weeks before investigational product administration.
12. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

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

📍 All Participating Trial Locations (1 Sites)

• MD Anderson Cancer Center — Houston, Texas

📞 Contact the Study Coordinator

Phone: (877) 632-6789

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.

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💡 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.