A Study of Experimental TTX-030 With or Without Immunotherapy or Chemotherapy for Advanced Cancers

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: lymphoma, solid tumor malignancies, cancer
Type: Drug study, Phase 1
Target:
10 Participants
Investigator:
Description
You are invited to take part in a voluntary research study to test an investigational drug called TTX-030. It will be given alone or in combination with either one of the FDA-approved drugs: Pembrolizumab, Docetaxel, or Gemcitabine and Nab-paclitaxel.

The purpose of this research study is to find out the highest dose of TTX-030 that can be given to subjects. We hope to learn its side effects, the level of investigational drug in your blood and how the body gets rid of the drug after dosing.

This study involves 4 treatment groups (arms). An ARM of a research study is a group of patients receiving a specific treatment. Treatment visits will involve Arms 1, 2, 3, which is a 21- day cycle, and Arm 4, a 28-day cycle. One cycle is 21 or 28 days, which is equivalent to 3 or 4 weeks, depending which Arm you participate in. You will visit the study site 4-5 times during Cycle 1, 2 times during Cycle 2, 1-2 times during Cycle 3, and 1 time for each following cycle.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion Criteria

  1. Age 18 years or older and is willing and able to provide informed consent
  2. Fresh and/or archival tumor tissue is optional for dose escalation; fresh tumor tissue at baseline (taken after prior treatment ended) and on-treatment are mandatory for expansion cohorts.
  3. Evidence of measurable disease by computed tomography (CT), CT-positron-emission tomography (PET-CT), or magnetic resonance imaging (MRI). (NOTE: Patients with prostate cancer may instead have evaluable disease on bone scan per PCWG3 4. Criteria and are not required to have Response Evaluation Criteria in Solid Tumors [RECIST] measurable disease.)
  4. Life expectancy > 12 weeks
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  6. Demonstrated adequate organ function, including: a. Oxygen saturation ≥ 92% on room air b. Absolute neutrophil count (ANC) ≥ 1.5 k/µL, platelets (PLT) ≥ 75 k/µL [PLT ≥ 100 k/µL required for chemotherapy arms], hemoglobin (Hgb) ≥ 8 g/dL [Hgb ≥ 9 g/dL for chemotherapy arms]. NOTE: Prior red blood cell transfusion is allowed. c. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 40 mL/min d. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x ULN (or ≤ 5 x ULN with liver metastases) e. Total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN with Gilbert’s syndrome) f. Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.2 x ULN; fibrinogen ≥ 150 mg/dL
  7. At least 28 days since last dose of chemotherapy or biological therapy, or at least 14 days since last dose of tyrosine kinase inhibitor or high-dose (e.g., > 10 mg prednisone or equivalent) steroid therapy prior to first dose of study treatment.
  8. Resolution of adverse effects from any prior chemotherapy, immunotherapy, or prior systemic anti-cancer therapy, radiotherapy, or surgery to Grade 1 or baseline (except Grade 2 alopecia and Grade 2 sensory neuropathy).
  9. Women of childbearing potential and all men must agree to use highly effective methods of birth control through 120 days after the last dose of study treatment NOTE: Highly effective contraception methods include: - Total abstinence - Female sterilization (tubal ligation, bilateral oophorectomy, and/or hysterectomy) - Male sterilization, at least 6 months prior to screening - Intrauterine device - Oral, injected, or implanted hormonal contraception AND barrier methods of contraception
  10. Participant is willing to comply with and able to tolerate study procedures

Exclusion Criteria: 1. History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody (mAb) should also be excluded. 2. Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study 3. Prior surgery or radiotherapy within 14 days of study treatment 4. Receiving high-dose (e.g., > 10 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment. NOTE: Inhaled, intranasal, intraocular, topical, and intraarticular steroids are allowed. Transient steroid administration as anti-emetic or chemotherapy pre-conditioning (e.g., for paclitaxel) is allowed per institutional guidelines. 4. Receiving therapeutic anticoagulation. NOTE: Low molecular weight heparin, Factor Xa inhibitors, and low-dose aspirin are allowed for deep vein thrombosis (DVT) prophylaxis. 5. History of autoimmune disease requiring systemic treatment or transplant that requires systemic steroids or immunosuppressive agents. NOTE: History of vitiligo, autoimmune thyroiditis, or mild psoriasis are allowed. 6. Known history of human immunodeficiency virus (HIV) or other chronic immunodeficiency 7. Uncontrolled intercurrent illness including, but not limited to: a. Uncontrolled diabetes with hemoglobin A1c (HgbA1c) ≥ 8.0% b. Ongoing or active bacterial, viral, or fungal infection requiring systemic treatment c. Clinically significant congestive heart failure defined by New York Heart Association (NYHA) Class 3 or Class 4 d. Unstable angina, arrhythmia, or myocardial infarction within 6 months prior to Screening 8. Known brain metastases or central nervous system (CNS) involvement. NOTE: Patients with asymptomatic and stable brain metastases following prior treatment may be eligible. 9. Other active malignancy requiring ongoing treatment 10. Women who are pregnant or breastfeeding

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
Your time in this research study will be followed in “cycles”. One cycle is 21 days (3 weeks) in duration for Arms 1-3 and 28 days (4 weeks) in duration for Arm 4. You will need to come to the study site 2-3 times before you begin to receive the drug to see if you are eligible to be in the study. After you start the drug(s), you will visit the study site 4-5 times during Cycle 1, 2 times during Cycle 2, 1-2 times during Cycle 3, and 1 time for each following cycle. The total number of cycles you go through in the study will depend on how you tolerate the drug, and if your cancer gets worse. The average number of expected cycles for a patient is 7 . You may be able to continue to take the drug as long as: • your cancer does not get worse • you do not have severe side effects • both the study doctor and the sponsor agree
Recruitment period
From June 5, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Solid Tumor
  • Lymphoma