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Monoclonal Antibodies
TU2218 + Pembrolizumab for Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by TiumBio Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up os rate at 6 months = up to 24 weeks
Awards & highlights
Study Summary
This trial looks at safety, effectiveness and how drugs interact in advanced solid tumor patients. Phases 1b and 2a help determine drug doses and efficacy.
Who is the study for?
Adults with advanced solid tumors who have adequate organ function, can comply with the study protocol, and are not pregnant or breastfeeding. They must have measurable disease, a life expectancy of at least 12 weeks, and for certain cohorts, be naive to specific treatments or have progressed after them. Participants should not be on conflicting medications or have conditions that could affect their safety in the trial.Check my eligibility
What is being tested?
The trial is testing TU2218 combined with Pembrolizumab to assess its safety and effectiveness against advanced solid tumors. Phase 1b aims to find the right dose while phase 2a focuses on how well it works for selected tumor types.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions like fever or chills, fatigue, digestive issues like nausea or diarrhea, blood disorders including anemia or clotting problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ os rate at 6 months = up to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~os rate at 6 months = up to 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: To determine the Recommended Phase 2 Dose of the Combination (RP2DC) of TU2218 given with Pembrolizumab in selected advanced solid tumors
Phase 2a: To evaluate the efficacy of TU2218 by evaluating the Overall Response rate (ORR) of TU2218 administered in combination with Pembrolizumab in selected advanced solid tumors
Secondary outcome measures
Clinical Benefit Rate (CBR)
Disease Control Rate (DCR)
Duration of Response (DoR)
+4 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
4Treatment groups
Experimental Treatment
Group I: TU2218 + Pembrolizumab in Colorectal Cancer (CRC) expansion cohort Phase 2aExperimental Treatment1 Intervention
A RP2DC of TU2218 + Pembrolizumab administered, orally BID, for 2 weeks followed by 1 week of rest in 3-week cycles for TU2218 and intravenous 200mg once every 3 weeks for Pembrolizumab to patients with CRC to see whether TU2218 has potential to reverse resistance to an anti-PD-(L)1 agent.
Group II: TU2218 + Pembrolizumab in Cervical Cancer (CC) expansion cohort Phase 2aExperimental Treatment1 Intervention
A RP2DC of TU2218 + Pembrolizumab administered, orally BID, for 2 weeks followed by 1 week of rest in 3-week cycles for TU2218 and intravenous 200mg once every 3 weeks for Pembrolizumab to patients with CC to see whether TU2218 has potential to reverse resistance to an anti-PD-(L)1 agent.
Group III: TU2218 + Pembrolizumab in Biliary Tract Cancer (BTC) expansion cohort Phase 2aExperimental Treatment1 Intervention
A RP2DC of TU2218 + Pembrolizumab administered, orally BID, for 2 weeks followed by 1 week of rest in 3-week cycles for TU2218 and intravenous 200mg once every 3 weeks for Pembrolizumab to patients with BTC to see whether TU2218 has potential to reverse resistance to an anti-PD-(L)1 agent.
Group IV: TU2218 + Pembrolizumab Phase 1bExperimental Treatment1 Intervention
Escalating doses of TU2218 orally and Pembrolizumab intravenously administered daily for two weeks followed by one week to determine RP2DC.
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Who is running the clinical trial?
TiumBio Co., Ltd.Lead Sponsor
3 Previous Clinical Trials
360 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,529 Total Patients Enrolled
TU2218Study DirectorTiumBio Co., Ltd.
1 Previous Clinical Trials
240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of severe bleeding or risk factors for it.I have a moderate or severe problem with my heart valve.I have received a transplant from another person.I have been treated before for my condition with drugs targeting TGF-Beta.I have heart or blood clot issues.My blood pressure is not controlled with medication.I have stopped or previously received certain medications.My liver and kidney functions are normal.My advanced cancer cannot be surgically removed and has not responded to or tolerated standard treatments.My cancer has spread to specific parts of my body.I am a female.My cervical cancer has worsened despite treatment including an anti-PD-(L)1 inhibitor.I have severe heart failure.I am fully active or can carry out light work.I have a history of heart problems.I understand and can follow all study rules.I am not currently receiving any cancer treatments.I have not had a heart attack or fluid around my heart in the last 6 months.I have a condition that affects how my body absorbs food or medicine.I have an immune system disorder or I'm on long-term steroids.I have had cancer treatment recently.I have not had any live vaccines recently.I have had radiotherapy recently.I cannot or will not stop taking certain medications.I have not had heart or aortic surgery in the last year.Any side effects from previous treatments have mostly gone away.I am not pregnant and agree to use contraception.I have a history of specific health conditions.I am currently on antibiotics for an infection.I am 18 years old or older.I can swallow pills.I finished my radiotherapy at least 2 weeks ago and have minimal side effects.My colorectal cancer is MSS type, hasn't responded to 2+ treatments, and I haven't had anti-PD-(L)1 drugs.My bile duct cancer has worsened after standard treatments and I haven't had anti-PD(L)1 therapy.My blood counts and clotting are normal.I have had another type of cancer.I have had lung inflammation or scarring before.
Research Study Groups:
This trial has the following groups:- Group 1: TU2218 + Pembrolizumab Phase 1b
- Group 2: TU2218 + Pembrolizumab in Biliary Tract Cancer (BTC) expansion cohort Phase 2a
- Group 3: TU2218 + Pembrolizumab in Cervical Cancer (CC) expansion cohort Phase 2a
- Group 4: TU2218 + Pembrolizumab in Colorectal Cancer (CRC) expansion cohort Phase 2a
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this research endeavor currently an option?
"Affirmative. The clinicaltrials.gov website confirms that this medical experiment, originally posted on 10th March 2023, is currently recruiting patients. Approximately 142 people are required to be enrolled from 3 different sites."
Answered by AI
What aims are we hoping to accomplish with this trial?
"This study seeks to evaluate the efficacy of TU2218 when combined with pembrolizumab in advanced solid tumors. The primary outcome measure over a 21-day period (Cycle 1) will be Overall Response Rate (ORR). Secondary objectives include examining pharmacokinetics, Time to Progression and Duration of Response."
Answered by AI
What is the volume of participants in this scientific trial?
"Affirmative. Clinicaltrials.gov notes that this medical trial which initiated on March 10th, 2023 is currently recruiting patients in a variety of locations. A total of 142 participants are required from 3 sites for the study to be successful."
Answered by AI
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