Rectal Cancer Clinical Trials
Rectal cancer clinical trials allow researchers to study the immediate and long-term effects of promising new therapies. Through these trials, participants can gain access to innovative treatments before those treatments are made widely available for use in other settings. For instance, one recent study compared a new robotic surgery technique to a commonly recommended minimally invasive procedure, while another trial introduced a new drug into a standard rectal cancer chemotherapy plan. Participants were able to access these novel therapies under the care of their oncologists, working together to take a proactive approach to treatment.
Most commonly, clinical trials compare a novel therapy to an existing one; this helps researchers determine which treatment is most effective or causes the fewest side effects. In other situations, rectal cancer clinical trials can be used to:
- Develop new diagnostic techniques or find other methods of improving early detection rates
- Evaluate various ways to reduce the chances of recurrence
- Improve quality of life outcomes during or after treatment
- Learn more about the various risk factors associated with the condition
Clinical trials for rectal cancer are a large part of Moffitt Cancer Center’s commitment to research. We conduct a wide range of scientific studies to help expand our range of treatment options and improve our patient outcomes, and many of our trials have led to significant breakthroughs in the field of colorectal cancer treatment. For our efforts, we have been named a Comprehensive Cancer Center by the National Cancer Institute. We are the only such center based in Florida.
Patients who are interested in learning more about our rectal cancer clinical trials can call 1-813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form online. Referrals are not required to participate.
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Clinical Trials
CLINICAL TRIAL 16028
Transdisciplinary Research in Colorectal Cancer: The ColoCare Study
Condition: Gastrointestinal Tumor
Intervention:
CLINICAL TRIAL 21589
BASECAMP-1: An Observational Study Obtaining Solid Tumor Tissue from Subjects with Primary Surgical Resection and Leukapheresis for CAR T-Cell Therapy Manufacturing
Condition: Immunotherapy
Intervention:
CLINICAL TRIAL 21641
First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGF_ Fusion Protein BCA101 Alone and in Combination with Pembrolizumab in Patients With EGFR-Driven Advanced Solid Tumors
Condition: Head & Neck
Intervention: BCA101 (); Pembrolizumab (Keytruda)
CLINICAL TRIAL 23064
Phase 1 Single Center Study to Evaluate Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Single Agent Mitomycin C (MMC) in Peritoneal Carcinomatosis (PC) from Solid Gastrointestinal Malignancies (sGI-PC) in Palliative Setting
Condition: Gastrointestinal Tumor
Intervention: Fluorouracil (); leucovorin (); mitomycin c ()
CLINICAL TRIAL 23309
A Platform Study of RAS(ON) Inhibitors to Treat Patients with Gastrointestinal Solid tumor - SUB-A: Study of RMC-6236 in Combination with 5-flourouracil-based regimens in Patients with Unresectable or Metastatic Colorectal Cancer or Metastatic Pancreatic Ductal Adenocarcinoma, - SUB: Study of RMC-6236 in Combination with Cetuximab with or without mFOLFOX6 in Patients with Unresectable or Metastatic Colorectal Cancer or Metastatic Pancreatic Ductal Adenocarcinoma, - SUB-C: Study of RMC-6236 in Combination with Gemcitabine and Nab-paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma - SUB-D: Study of RMC-9805 with or without RMC-6236 in Combination with 5-flourouracil-based Therapies in Patients with RAS G12D-Mutant Unresectable or Metastatic Colorectal Cancer or Metastatic Pancreatic Ductal Adenocarcinoma - SUB-E: Study of RMC-9805 with or without RMC-6236 in Combination with Cetuximab-based Therapies in Patients with RAS G12D-Mutant Unresectable or Metastatic Colorectal Cancer or Metastatic Pancreatic Ductal Adenocarcinoma - SUB-F: Study of RMC-9805 With or Without RMC-6236 in Combination with Gemcitabine and Nab-Paclitaxel in Patients with RAS G12D-Mutant Metastatic Pancreatic Ductal Adenocarcinoma
Condition: Gastrointestinal Tumor
Intervention: 5-fluorouracil (); Avastin (Bevacizumab); Bevacizumab (); CPT-11 (irinotecan); Camptosar (irinotecan); Cetuximab (); Daraxonrasib (); Erbitux (Cetuximab); Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); Oxaliplatin (); RMC-6236 (Daraxonrasib); RMC-9805 (Zoldonrasib); Zoldonrasib (); eloxatin (Oxaliplatin); gemcitabine (); irinotecan (); leucovorin (); mFOLFIRINOX (); mFOLFOX6 ()
CLINICAL TRIAL 23448
A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients with Solid Tumors with KRASG12D Mutation
Condition: Multiple
Intervention: Cemiplimab (); Cetuximab (); Erbitux (Cetuximab); Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); Pembrolizumab (Keytruda); QTX3034 (); REGN2810 (Cemiplimab); gemcitabine (); mFOLFOX6 ()
CLINICAL TRIAL 23464
ColoCare GO
Condition: Gastrointestinal Tumor
Intervention:
CLINICAL TRIAL 23549
A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination with Atezolizumab in Patients with Advanced Solid Tumors
Condition: Thoracic
Intervention: Atezolizumab (Tecentriq); VET3-TGI ()
CLINICAL TRIAL 23585
A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects with Advanced Solid Tumors (The BREAKER-101 Trial)
Condition: Breast
Intervention: Avastin (Bevacizumab); BBO-10203 (); Bevacizumab (); FOLFOX (); Faslodex (fulvestrant); Herceptin (Trastuzumab); LEE011 (Ribociclib); Ribociclib (); Trastuzumab (); fulvestrant (); rhuMAb HER2 (Trastuzumab)
CLINICAL TRIAL 23599
Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects with Advanced KRAS Mutant Cancers
Condition: Multiple
Intervention: Alimta (Pemetrexed); BBO-10203 (); BBO-11818 (); Cetuximab (); Erbitux (Cetuximab); FOLFOX (); Gemzar (gemcitabine); NALIRIFOX (); Nab-paclitaxel (Abraxane); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); carboplatin (); cisplatin (); gemcitabine (); mFOLFIRINOX (); mFOLFOX6 ()
CLINICAL TRIAL 23553
DENALI-1: A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod CAR T, in Heterozygous HLA A*02 Adults with Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA A*02 Expression.
Condition: Immunotherapy
Intervention: A2B395 (); MESNA (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
CLINICAL TRIAL 23625
A Phase 2, Randomized, Open-Label Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to the Current Standard of Care in Subjects with Post Adjuvant ctDNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (NED)
Condition: Gastrointestinal Tumor
Intervention: Telisotuzumab Adizutecan ()
CLINICAL TRIAL 23660
A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants with Advanced or Metastatic Solid Tumors
Condition: Multiple
Intervention:
CLINICAL TRIAL 23766
A First-in-Human Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FID-022 as Monotherapy in Patients with Advanced Solid Tumors
Condition: Multiple
Intervention: FID-022 ()
CLINICAL TRIAL 23787
A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors
Condition: Multiple
Intervention: ALX2004 ()
CLINICAL TRIAL 23829
A Phase 1/2 First-in-Human, Open-Label, Dose Escalation and Expansion Trial of TAK-505 Monotherapy in Participants with Unresectable Locally Advanced or Metastatic Solid Tumors
Condition: Multiple
Intervention: TAK-505 ()
CLINICAL TRIAL 23924
Blood-Based Biomarkers for the Minimally-Invasive Detection of Colorectal Cancer
Condition: Gastrointestinal Tumor
Intervention:
CLINICAL TRIAL 23993
A Phase 1a/1b, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMGS-001 in Patients with Relapsed or Refractory Advanced Solid Tumors
Condition: Multiple
Intervention: IMGS-001 ()
CLINICAL TRIAL 23967
ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination with Chemotherapy in Participants with Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
Condition: Gastrointestinal Tumor
Intervention: 5-fluorouracil (); CPT-11 (irinotecan); Camptosar (irinotecan); Oxaliplatin (); Pumitamig / Bevacizumab (); Xeloda (capecitabine); capecitabine (); eloxatin (Oxaliplatin); irinotecan (); leucovorin ()
CLINICAL TRIAL 23990
AndroMETa-CRC-560: An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer
Condition: Gastrointestinal Tumor
Intervention: Avastin (Bevacizumab); Bevacizumab (); Telisotuzumab Adizutecan (); Trifluridine + Tipiracil ()
CLINICAL TRIAL 24028
OMNIRAY, A Phase 1a/b Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults with GRPR-Positive Advanced Solid Tumors
Condition: Multiple
Intervention: Abemaciclib (); Anastrozole (); Arimadex (Anastrozole); Aromasin (Exemestane); Exemestane (); Faslodex (fulvestrant); Femara (Letrozole); Imlunestrant (); LY2835219 (Abemaciclib); LY4257496 (); LY4257529 (); Letrozole (); Xeloda (capecitabine); capecitabine (); fulvestrant ()
CLINICAL TRIAL 24059
Master Data and Biospecimen Collection Protocol to Improve Outcomes for Young Adults with Gastrointestinal Cancer
Condition: Gastrointestinal Tumor
Intervention:
CLINICAL TRIAL 24071
Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients with Advanced KRAS G12V-Mutant Solid Tumors
Condition: Multiple
Intervention: Cetuximab (); Daraxonrasib (); Erbitux (Cetuximab); RMC-5127 (); RMC-6236 (Daraxonrasib)
CLINICAL TRIAL 24082
Using Automated Biochips to Assist in Specific Chemotherapy Selection in Pancreatic and Colorectal Cancer Patients
Condition: Gastrointestinal Tumor
Intervention:
CLINICAL TRIAL 24103
A First-in-Human Phase 1 Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KST-6051 in Patients With Advanced or Metastatic Solid Tumors With a KRAS Mutation
Condition: Multiple
Intervention: KST-6051 ()
CLINICAL TRIAL 24236
A Phase 1 First-in-Human Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-0015 Monotherapy and in Combination in Patients with Advanced Solid Tumors
Condition: Multiple
Intervention: 5-fluorouracil (); Alimta (Pemetrexed); ERAS-0015 (); Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); Oxaliplatin (); Panitumumab (); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); Taxotere (docetaxel); Vectibix (Panitumumab); carboplatin (); cisplatin (); docetaxel (); eloxatin (Oxaliplatin); gemcitabine (); leucovorin ()
CLINICAL TRIAL 24258
A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants with Advanced Gastrointestinal Cancers
Condition: Immunotherapy
Intervention: Cyclophosphamide (); DV-10 (); Fludarabine (); Idecabtagene Vicleucel ()
CLINICAL TRIAL 24278
A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, With and Without an Anti-EGFR Antibody, and With an Anti-EGFR Antibody and Chemotherapy, in Patients With Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma (TARGET-D 203)
Condition: Gastrointestinal Tumor
Intervention: 5-fluorouracil (); Cetuximab (); Erbitux (Cetuximab); Oxaliplatin (); Panitumumab (); VS-7375 (); Vectibix (Panitumumab); eloxatin (Oxaliplatin); leucovorin ()
CLINICAL TRIAL 24299
A study of a mutant-selective inhibitor, CGT6297, in patients with advanced solid tumors harboring PIK3CA mutations
Condition: Multiple
Intervention: CGT6297 ()
CLINICAL TRIAL 24394
A Multi-center, Open-label, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AN9025 in Participants with Advanced or Metastatic Solid Tumors Harboring RAS Mutations
Condition: Multiple
Intervention: AN9025 ()