TTI-101 + Radiotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen by David Binder, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

To evaluate the safety, tolerability, and efficacy of TTI-101 given in combination with Stereotactic Body Radiation Therapy (SBRT) in borderline resectable pancreatic ductal adenocarcinoma.

Do I need to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you must stop using herbal medications 7 days before the first dose. Senna and flaxseed are allowed.

What data supports the idea that TTI-101 + Radiotherapy for Pancreatic Cancer is an effective treatment?

The available research does not provide specific data on the effectiveness of TTI-101 combined with radiotherapy for pancreatic cancer. Instead, it discusses other treatments and strategies, such as combining chemotherapy with radiotherapy or using targeted therapies with radiotherapy. These studies suggest that combining different treatments can improve outcomes for pancreatic cancer patients, but there is no direct evidence for TTI-101 in the provided information. ^{1 2 3 4 5}

What safety data is available for TTI-101 and radiotherapy in pancreatic cancer treatment?

The provided research abstracts do not directly mention TTI-101, C-188-9, or any of its variants in combination with radiotherapy for pancreatic cancer. The studies focus on radiotherapy techniques and their associated toxicities, such as gastrointestinal toxicity, in pancreatic cancer treatment. However, they do not provide specific safety data for TTI-101 or its combinations. Further research specifically involving TTI-101 would be needed to determine its safety profile in this context. ^{6 7 8 9 10}

Is the drug TTI-101 a promising treatment for pancreatic cancer?

TTI-101, when combined with radiotherapy, could be promising for treating pancreatic cancer because radiotherapy has shown benefits in managing the disease, especially when surgery isn't an option. Combining it with a new drug like TTI-101 might improve outcomes. ^{8 10 11 12 13}

Research Team

David Binder, MD, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for adults with borderline resectable pancreatic cancer who've had chemotherapy. They must be able to swallow pills, have certain blood cell counts and organ function levels, not be pregnant or breastfeeding, agree to use contraception, and can't have other serious health issues or recent major surgery.

Inclusion Criteria

Stated willingness to comply with all study procedures and be available for the duration of the study.

My blood clotting time is normal or managed with medication.

I have a specific type of pancreatic cancer that is almost operable.

Exclusion Criteria

I have been symptom-free from COVID-19 for at least 2 weeks.

I have serious heart problems, including recent heart attack or severe heart failure.

I have had episodes of brain confusion due to liver problems.

Treatment Details

Interventions

• TTI-101 (Virus Therapy)

Trial Overview The trial tests TTI-101 combined with Stereotactic Body Radiation Therapy (SBRT) in treating pancreatic ductal adenocarcinoma. It aims to assess the safety and effectiveness of this combination therapy in patients whose condition allows for potential surgical removal of the tumor.

Participant Groups

Group I: Phase II Experimental Treatment 1 Intervention

An additional 12 patients will be enrolled in phase 2 so that total of 18 patients are treated at RP2D in phase 2 (the 6 patients treated at RP2D in phase 1 will be rolled over to phase 2) of TTI-101 in combination with SBRT.

Group II: Phase I Experimental Treatment 1 Intervention

During Phase 1, up to 2 dose levels of TTI-101 with SBRT will be tested using a 3 + 3 dose-escalation design to determine the RP2D. Up to 3 participants may be enrolled with either 0/3 or 1/3 DLT in order to more fully evaluate the safety and tolerability at a given dose level. Therefore, a minimum of 9 patients (3 at dose 0, and 6 at dose 1) and maximum 18 (6 patients at each dose level) will be enrolled in the phase 1.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Colorado Aurora, CO

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1842

Patients Recruited

3,028,000+

Tvardi Therapeutics, Incorporated

Industry Sponsor

Trials

5

Patients Recruited

360+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triple modal treatment comprising with proton beam radiation, hyperthermia, and gemcitabine/nab-paclitaxel for locally advanced pancreatic cancer: a phase I/II study protocol (TT-LAP trial). Shimomura, O., Endo, M., Makishima, H., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemoradiotherapy versus chemotherapy for locally advanced unresectable pancreatic cancer: A systematic review and meta-analysis. Ng, IW., Soon, YY., Chen, D., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting DNA repair in combination with radiotherapy in pancreatic cancer: A systematic review of preclinical studies. Waissi, W., Paix, A., Nicol, A., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical assessment of palliative radiotherapy for pancreatic cancer. Tian, Q., Zhang, F., Wang, Y.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five year results of US intergroup/RTOG 9704 with postoperative CA 19-9 ≤90 U/mL and comparison to the CONKO-001 trial. Berger, AC., Winter, K., Hoffman, JP., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive dosimetric parameters for gastrointestinal toxicity with hypofractioned radiotherapy in pancreatic adenocarcinoma. Liu, X., Ren, G., Li, L., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Proton Beam Therapy Compared With Intensity-Modulated Radiation Therapy for Uterine Cancer. Anderson, JD., Voss, MM., Laughlin, BS., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose escalation in locally advanced pancreatic cancer patients receiving chemoradiotherapy. Chung, SY., Chang, JS., Lee, BM., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of radiation dose escalation with concurrent weekly full-dose gemcitabine in patients with advanced pancreatic cancer. McGinn, CJ., Zalupski, MM., Shureiqi, I., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated radiochemotherapy in pancreatic cancer is not necessarily related to a pathologic pancreatic function decline in the early period. Horst, E., Seidel, M., Micke, O., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed Tomography-guided 125I Radioactive Seed Implantation Therapy for Pancreatic Cancer Pain. Fan, T., Zhou, JY.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of radiation therapy in the management of the patient with pancreatic cancer. Abrams, RA.[2005]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SU-E-T-256: Radiation Dose Responses for Chemoradiation Therapy of Pancreatic Cancer: An Analysis of Compiled Clinical Data Using Biophysical Models. Moraru, I., Tai, A., Erickson, B., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Triple modal treatment comprising with proton beam radiation, hyperthermia, and gemcitabine/nab-paclitaxel for locally advanced pancreatic cancer: a phase I/II study protocol (TT-LAP trial). [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

Chemoradiotherapy versus chemotherapy for locally advanced unresectable pancreatic cancer: A systematic review and meta-analysis. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Targeting DNA repair in combination with radiotherapy in pancreatic cancer: A systematic review of preclinical studies. [2020]

4. France pubmed.ncbi.nlm.nih.gov

Clinical assessment of palliative radiotherapy for pancreatic cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Five year results of US intergroup/RTOG 9704 with postoperative CA 19-9 ≤90 U/mL and comparison to the CONKO-001 trial. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Predictive dosimetric parameters for gastrointestinal toxicity with hypofractioned radiotherapy in pancreatic adenocarcinoma. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Proton Beam Therapy Compared With Intensity-Modulated Radiation Therapy for Uterine Cancer. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Dose escalation in locally advanced pancreatic cancer patients receiving chemoradiotherapy. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Phase I trial of radiation dose escalation with concurrent weekly full-dose gemcitabine in patients with advanced pancreatic cancer. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Accelerated radiochemotherapy in pancreatic cancer is not necessarily related to a pathologic pancreatic function decline in the early period. [2019]

11. Pakistan pubmed.ncbi.nlm.nih.gov

Computed Tomography-guided 125I Radioactive Seed Implantation Therapy for Pancreatic Cancer Pain. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Role of radiation therapy in the management of the patient with pancreatic cancer. [2005]

13. United States pubmed.ncbi.nlm.nih.gov

SU-E-T-256: Radiation Dose Responses for Chemoradiation Therapy of Pancreatic Cancer: An Analysis of Compiled Clinical Data Using Biophysical Models. [2019]