Gastrointestinal Cancer Trials

Every treatment that has ever made a difference in cancer care was once a part of a clinical trial. MUSC Hollings Cancer Center is committed to offering the best treatments available today while searching for even better ones for the future. Ask your doctor if a clinical trial is right for you.

STUDY17022
First in Human, Phase 1/1b, Open label, Multicenter Study of Bifunctional EGFR/TGF ß Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients with EGFR Driven Advanced Solid Tumors

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

Study Information
STUDY20051
Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High Risk Pancreatic Neuroendocrine Tumors

This phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.

Study Information
STUDY21781
A Phase 1 Dose Escalation Study of AV-380 in Combination with Standard of Care Chemotherapy in Metastatic Cancer Patients with Cachexia and Elevated GDF-15 Levels

To refine the dose and schedule of AV-380 and establish its adverse event (AE), pharmacokinetic (PK), and pharmacodynamic (PD) profile in metastatic cancer patients with cachexia and elevated GDF-15, receiving SoC chemotherapy for metastatic cancer

Study Information
STUDY22555
Randomized Phase III Trial of M-Folfirinox +/- Nivolumab vs. Folfox +/- Nivolumab for First Line Treatment of Metastatic HER-2 Negative Gastroesophageal Addenocarcinoma

To determine if overall survival (OS) is improved in patients who received mFOLFIRINOX +/- nivolumab in comparison to FOLFOX +/- nivolumab as first-line chemotherapy for metastatic gastroesophageal adenocarcinoma. To compare other indices of efficacy, including progression-free survival, objective response rates and duration of response between both treatment arms. To evaluate safety and tolerability associated with treatment in each of the treatment arms. To evaluate the proportion of patients receiving second line of therapy in both arms. To evaluate tolerability of the treatment in both arms using PRO-CTCAE

Study Information
STUDY22631
Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC #783608) in Patients with Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)

Among patients with metastatic extrapulmonary poorly differentiated small cell NEC, to compare overall survival (OS, measured from randomization) in a fixed sequence as follows: a. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus induction platinum/etoposide alone (Arm 3) b. Compare the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2) versus induction platinum/etoposide alone (Arm 3) c. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2)

Study Information
STUDY23504
A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination with Fluorouracil, Folinic Acid, and Bevacizumab and to Evaluate Safety and Efficacy of ABBV-400 in Combination with Bevacizumab in Previously Treated Subjects with Unresectable Metastatic Colorectal Cancer

To optimize ABBV-400 dose in combination with 5-FU, folinic acid, and bevacizumab to determine the RP3D regimen for the combination. To evaluate the efficacy as measured by OR and PFS of ABBV-400 in combination with 5-FU, folinic acid, and bevacizumab, To evaluate the safety and tolerability of ABBV-400 in combination with 5-FU, folinic acid, and bevacizumab.

Study Information
STUDY23847
Phase II Study Evaluating NALIRIFOX versus Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients with Locally Advanced and Metastatic Pancreatic Adenocarcinoma

Compare the anti-tumor activity of the NALIRIFOX and mGAP regimens in patients with locally advanced, unresectable, and metastatic PDAC. To assess the safety of the NALIRIFOX and mGAP regimens in patients with locally advanced, unresectable, and metastatic PDAC. To evaluate the anti-tumor activity of the NALIRIFOX and mGAP regimens in patients with locally advanced, unresectable, and metastatic PDAC.

Study Information
STUDY23849
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors

This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD and/or RP2D. Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1311 as monotherapy.

Study Information
STUDY23968
A Multicenter, Open-Label Phase 1/1B Dose-Finding, Safety, and Pharmacokinetic Study of MBRC-101, an Anti-EPHA5 Monomethyl Auristatin E (MMAE) Antibody Drug Conjugate, in Advanced Refractory Solid Tumors

To identify potential OBRD and dosing regimens of MBRC-101. To establish the MTD of MBRC-101 using 1 or more dosing regimens. To identify potential RP2Ds and regimens of MBRC-101. To evaluate the safety of MBRC-101 at potential OBRDs, RP2Ds, and dosing regimens. To evaluate preliminary clinical activity of MBRC-101.

Study Information
STUDY24691
A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults with Selected Advanced Solid Tumors

Evaluate the safety of APL-5125. Determine recommended phase 2 dose (RP2D) levels of APL-5125. Estimate the maximum tolerated dose (MTD) of APL-5125 in participants with selected advanced solid tumors.

Study Information