2024
Annual Report
Clinical Trials
Clinical trials are essential to CPRIT’s mission to accelerate innovative options available to doctors and patients to prevent, detect, treat, and cure cancer in Texas. CPRIT offers at least seven different academic research and product development research grants supporting projects that expand access and increase availability of clinical trials.
Clinical trials are medical studies to evaluate the effectiveness of new treatments in human participants. The studies can be interventional or observational. Participants receive specific interventions, like an experimental drug or a change to participants’ behavior (e.g., diet), in interventional clinical trials. Observational studies focus on health outcomes in participants receiving standard medical care.
For the scientific community, clinical trials provide the regulatory data necessary to translate laboratory discoveries safely and effectively into new treatments that save lives and improve outcomes. For patients, participating in a clinical trial provide access to innovative new treatments that are not yet available to the general public. This is particularly important for those suffering from difficult-to-treat cancers. For these patients, clinical trials provide hope in the form of novel treatments that can ease suffering or extend their life.
CPRIT’s Clinical Trials Advisory Committee (CTAC) provides expert opinion and advice to the Oversight Committee regarding opportunities to increase CPRIT’s impact on translating basic discoveries to clinical trials, the impact of CPRIT’s current clinical trial grants, and mechanisms to eliminate barriers to patient enrollment. The CTAC 2024 Annual Report can be found here.
Number of CPRIT-funded Clinical Trials
Number of Patients Enrolled in CPRIT-funded Clinical Trials
Number of clinical trial related CPRIT Request for Applications
Scroll ❮ left or right ❯ at bottom
Title:
Pre-Surgical Trial of Letrozole in Post-Menopausal Patients with Operable Hormone-Sensitive Breast Cancer
Grant:
RR170061
Grantee:
The University of Texas Southwestern Medical Center
Carlos Arteaga
Type / Phase:
Interventional · Pilot
This is a short pre-surgical non-therapeutic trial involving postmenopausal women with newly diagnosed eR+, HeR2-negative operable breast cancers. After undergoing a core needle biopsy for tissue acquisition, participants will take letrozole up to 30 days. Patients will undergo surgical resection of their tumor the day after the last dose of letrozole. They will then undergo definitive surgical resection of their primary tumor (mastectomy vs lumpectomy) as per standard of care guidelines. The primary lesion obtained at the time of surgery will be sent for standard of care histopathologic analysis and used fo rresearch purposes only.
Learn More: NCT03747042
Title:
Adaptation and Initial Evaluation of Transdiagnostic CBT for Anxious and Depressed Smokers
Grant:
RP200409
Grantee:
University of Houston
Matthew Gallagher
Type / Phase:
Interventional · Phase I, II
This study tests the effectiveness of a new treatment protocol for anxious and depressed smokers. Participants will receive either the standard smoking cessation treatment or the Unified Protocol for Smoking Cessation Treatment (UP-ST). The investigators will compare the UP-ST approach to standard treatment in addressing the smoking, anxiety, depression, and mechanisms of change. If successful, this single treatment protocol could offer a groundbreaking and widely applicable option to tackle address both smoking and the complex emotional comorbidities that are widespread in smokers, filling a critical gap in current smoking cessation strategies.
Learn More: NCT03920137
Title:
A randomized, controlled trial comparing the immunogenicity of 2 doses vs 3 doses of the 9-valent HPV vaccine in males and females 15–26 years of age
Grant:
RP190022
Grantee:
The University of Texas Medical Branch at Galveston
Abbey Berenson, M.D., Ph.D.
Type / Phase:
Interventional · Phase III, IV
The investigators are studying a delayed dosing schedule of an approved drug (Gardasil 9). The results of this randomized study will help determine whether 15-26 year old males and females need a 3rd dose of the human papillomavirus (HPV) vaccine, or whether 2 doses provide similar protection as 3 doses from the 9 types of HPV that it protects against.
Learn More: NCT0394875
Title:
T-DM1 and Tucatinib Compared with T-DM1 Alone in Preventing Relapses in People with High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
Grant:
RP210122
Grantee:
The University of Texas M. D. Anderson Cancer Center
Michael Overman
Type / Phase:
Interventional · Phase III
This phase III trial tests whether combining two targeted treatments, trastuzumab emtansine (T-DM1) and tucatinib, is more effective at preventing breast cancer relapse in patients with high-risk, HER2-positive breast cancer. T-DM1 uses a targeted approach to deliver chemotherapy directly to cancer cells, while tucatinib blocks enzymes that help cancer grow. Researchers hope the combination will work better than T-DM1 alone in preventing relapse in patients with HER2-positive breast cancer.
Learn More: NCT04457596
Title:
"A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-401) Administered to Patients With Acute Myeloid Leukemia (AML) Following Hematopoietic Stem Cell Transplantation "
Grant:
DP210042
Grantee:
Marker Therapeutics, Inc.
Juan Vera
Type / Phase:
Interventional · Phase II
This Phase 2 multicenter study evaluates the safety and effectiveness of MT-401 in patients with acute myeloid leukemia. Eligible participants are aged ≥18 years old who are undergoing or have relapsed after their first stem cell transplant.
Learn More: NCT04511130
Title:
"A Phase II, Multicenter, Prospective Study of Sacituzumab Govitecan in Recurrent Glioblastoma "
Grant:
RP210164
Grantee:
The University of Texas Health Science Center at San Antonio
William Kelly
Type / Phase:
Interventional · Phase II
This is an open-label single arm study investigating a new drug for recurrent glioblastoma patients. All participants will receive the investigational agent, Sacituzumab Govitecan (SG), an antibody-drug conjugate. The researchers are conducting this Phase II study to test the effectiveness of SG based on progression-free survival results at six months.
Learn More: NCT04559230
Title:
Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors
Grant:
RR160093
Grantee:
The University of Texas at Austin
Gail Eckhardt
Type / Phase:
Interventional · Phase I
The purpose of this Phase 1/1b study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of escalating doses of RMC-5552 monotherapy, a new treatment for advanced solid tumors, in adult participants with relapsed/refractory solid tumors. This study will identify the recommended Phase 2 dose and will explore its effects on tumors with specific mutations linked to mTOR pathway overactivity.
Learn More: NCT04774952
Title:
A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia
Grant:
RP220542
Grantee:
The University of Texas Southwestern Medical Center
David Gerber
Type / Phase:
Interventional · Phase III
This phase 3 trial compares the effects of olanzapine, a medication that may help increase appetite, versus the standard treatment, megestrol acetate, in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Researchers will measure changes in appetite using a 0-10 scale and compare results between the two study groups after four weeks of treatment.
Learn More: NCT04939090
Title:
Androgen Deprivation Therapy for Prostate Cancer
Grant:
RP210122
Grantee:
The University of Texas M. D. Anderson Cancer Center
Michael Overman
Type / Phase:
Interventional · Phase II
The purpose of the study is to assess whether adding the drug darolutamide to standard hormone therapy (ADT) works better than ADT alone for slowing the progression of prostate cancer in participants with metastatic hormone-sensitive prostate cancer. Researchers will track how long it takes for the cancer to worsen, based on symptoms, new growths, rising PSA levels, or death. Darolutamide is already approved for use in prostate cancer that has not yet spread and works by blocking a protein in cancer cells that relies on male hormones.
Learn More: NCT05059236
Title:
Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in Autologous T Cells for Hepatocellular Carcinoma
Grant:
RP190160
Grantee:
Baylor College of Medicine
Andras Heczey
Type / Phase:
Interventional · Phase I
This research study tests T cells genetically engineered with a GPC3-CAR and IL15 (CATCH T cells) in patients with GPC3-positive solid tumors. The purpose of this study is to identify the highest dose of CATCH T cells that can be safely administered, to see how long these T cells remain active in the patient’s bloodstream and tumor environment, to analyze adverse effects, and determine whether the CATCH T cells effectively reduce tumor size or slow disease progression in patients with GPC3-positive solid tumors.
Learn More: NCT05103631
Title:
A Pilot Study of Glutamine PET Imaging of Head and Neck Squamous Cell Carcinoma (HNSCC)
Grant:
RR200046
Grantee:
The University of Texas M. D. Anderson Cancer Center
Henry Manning
Type / Phase:
Interventional · Pilot
This clinical imaging trial will evaluate a new imaging method for head and neck cancer. The study evaluates 11C-Gln PET/CT followed by 18F-FSPG PET/CT in 20 head and neck squamous cell carcinoma patients (HNSCC). These scans help measure how cancer cells absorb certain nutrients, providing detailed information about tumor behavior. A long-term goal of these preliminary studies is to validate the utility of Gln PET imaging metrics for HNSCC and to expand this imaging technique to additional patients in prospective cohorts of patients with HNSCC.
Learn More: NCT05322135
Title:
POSTCare-O: Survivorship Care for Women Living with Ovarian Cancer
Grant:
RP220532
Grantee:
Baylor College of Medicine
Elizabeth Kvale
Type / Phase:
Interventional · Phase III
This study will enroll 120 women who have completed initial treatment for ovarian cancer. The objective is to test a telehealth program called POSTCare-O, designed to support women during their transition to survivorship, which addresses the long-term effects of cancer and its treatment, as well as the anxiety of potential recurrence. Researchers randomly assign study participants to receive survivorship care through the POSTCare-O telehealth program or standard care. The primary outcome is quality of life evaluated at 12 weeks after intervention.
Learn More: NCT05752448
Title:
Study of PULSAR-ICI +/- IMSA101 in Patients with Oligometastatic NSCLC and RCC
Grant:
DP220030
Grantee:
ImmuneSensor Therapeutics Inc.
Lijun Sun
Type / Phase:
Interventional · Phase II
This study tests two treatment approaches for patients with non-small cell lung cancer or renal cell carcinoma. Both treatments combine a specialized type of targeted radiation therapy (PULSAR) with ICI immunotherapy. One group will also receive an additional drug called IMSA101. After three 28-day cycles, participants will switch to standard immunotherapy based on current care guidelines. All patients will be assessed for anti-tumor efficacy at screening, prior to the end of Cycle 3, and at 8-week intervals thereafter based on radiographic assessments.
Learn More: NCT05846646
Title:
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship
Grant:
RP220204
Grantee:
The University of Texas Health Science Center at Houston
John Rasmussen
Type / Phase:
Interventional · Phase I
The goal of this clinical trial is to determine if early treatment can help prevent or slow the development of lymphedema in head and neck cancer survivors. The treatment group will use a home device for daily compression therapy, while the control group will receive treatment after diagnosis of lymphedema. Researchers will compare the incidence of lymphedema between the two groups after one year to see if treatment before diagnosis prevents the development and progression of head and neck lymphedema.
Learn More: NCT05937269
Title:
Reminder Messages for Lung Cancer Screening
Grant:
RP230213
Grantee:
The University of Texas M. D. Anderson Cancer Center
Robert Volk
Type / Phase:
Observational · Pilot
This study aims to develop, refine, and test reminder messages for lung cancer screening to ensure they are acceptable to patients who have a history of cigarette use. Adults who are 40 to 80 years of age, who smoke or have smoked, and who do not have a history of lung cancer by self-report will receive lung cancer screening reminder messages for an average of one year.
Learn More: NCT05952778
Title:
A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)
Grant:
RP200669
Grantee:
The University of Texas M. D. Anderson Cancer Center
Chad Tang
Type / Phase:
Interventional · Phase II
This study is testing whether adding one year of therapy with pembrolizumab (an immunotherapy) can help better control renal cell carcinoma after radiation therapy. The control group will receive radiation therapy and the experimental group will receive radiation therapy and pembrolizumab. The main goal is to monitor and compare side effects in both groups to evaluate the safety of this combined approach.
Learn More: NCT06004336
Title:
A First in-Human Phase 1a/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMGS-001 in Patients with Relapsed or Refractory Advanced Solid Tumors
Grant:
DP200094
Grantee:
Immunogenesis, Inc.
Michael Curran
Type / Phase:
Interventional · Phase I
The purpose of this Phase 1a/1b clinical trial is to test the safety of the investigational drug IMGS-001 and to determine if it is safe and effective for treating patients with relapsed or refractory advanced solid tumors. In Phase 1a, five different doses of IMGS-001 will be tested in patients to find the safest doses for further study. In Phase 1b, two doses identified from Phase 1a will be tested further to evaluate their safety and potential effectiveness in select cancer types.
Learn More: NCT06014502