Your session is about to expire
← Back to Search
Other
ETC-1922159 + Pembrolizumab for Advanced Cancers
Phase 1
Waitlist Available
Research Sponsored by EDDC (Experimental Drug Development Centre), A*STAR Research Entities
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capable of swallowing study medication or has caregiver responsible for administering study drug
Histologically/cytologically confirmed advanced or metastatic tumors, that are unresectable solid malignancies, and that are are refractory, intolerant or not suitable to available treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of enrolment to cycle 2 for dose escalation and cycle 1 of combination therapy for dose expansion
Awards & highlights
Study Summary
This trial is testing a new drug (ETC-1922159) for safety, how well it works, and what the best dose is. The trial has four parts, A-D. Parts A and A Extension have been completed and showed that the drug is safe and had some effect on the disease. In Part B, they will test different doses of the drug to find the best dose, and in Part C they will test the drug in combination with another drug.
Who is the study for?
Adults with advanced solid tumors that are not suitable for standard treatments. They must have measurable disease, a life expectancy of at least 3 months, and adequate organ function. Specific groups require certain genetic features or tumor types like MSS-CRC without specific gene fusions or MSS/pMMR ovarian and endometrial cancer.Check my eligibility
What is being tested?
The trial is testing ETC-1922159 alone and combined with Pembrolizumab in patients with advanced solid tumors. It's divided into parts: initial dose finding, safety evaluation with bone protective treatment, combination therapy dosing, and expansion to assess long-term effects.See study design
What are the potential side effects?
Potential side effects include typical reactions to cancer therapies such as fatigue, digestive issues, blood disorders; specific risks related to the drugs being tested will be monitored closely given this is an early-phase trial assessing safety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills or have someone to help me take my medication.
Select...
My cancer is advanced, cannot be surgically removed, and does not respond to current treatments.
Select...
I am able to get out of my bed or chair and move around.
Select...
I can provide a sample of my cancer tissue that meets the size and tumor content requirements.
Select...
My colorectal cancer has one of the specific gene fusions (A-D) involving RSPO2 or RSPO3.
Select...
My colorectal cancer lacks certain gene fusions.
Select...
My cancer has grown or spread, confirmed by recent scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for 2 cycles (42 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 2 cycles (42 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Eastern Cooperative Oncology Group performance status (Part B Dose Expansion)
Maximum Tolerated Dose (MTD) of ETC-1922159 when administered with pembrolizumab (Part B Dose Escalation)
Number of participants with abnormal 12-lead electrocardiogram (ECG) readings (Part B Dose Expansion)
+6 moreSecondary outcome measures
Change in Eastern Cooperative Oncology Group performance status (Part B Dose Escalation)
Clinical activity measured by RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1 and iRECIST (Response Evaluation Criteria in Solid Tumours modified for immune-based therapeutics) (Part B Dose Escalation)
Clinical activity measured by RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1 and iRECIST (Response Evaluation Criteria in Solid Tumours modified for immune-based therapeutics) (Part B Dose Expansion)
+10 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
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment2 Interventions
ETC-1922159 as single agent until disease progression, then in combination with pembrolizumab at the recommended dose (RD) identified in the dose escalation segment
Group II: Dose EscalationExperimental Treatment2 Interventions
ETC-1922159 + pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
EDDC (Experimental Drug Development Centre), A*STAR Research EntitiesLead Sponsor
2 Previous Clinical Trials
84 Total Patients Enrolled
PPDIndustry Sponsor
159 Previous Clinical Trials
36,826 Total Patients Enrolled
Wenyan Li, MBBS, PhDStudy DirectorPPD, Associate Medical Director
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have osteoporosis as shown by my DEXA scan results.My organs are functioning well.My bone density score is higher than -2.5.I have HIV or an active infection.You understand what the study involves and agree to participate willingly.My cancer is advanced, cannot be surgically removed, and does not respond to current treatments.You are expected to live for at least 3 more months.Your platelet count is at least 100 billion per liter of blood, and you haven't received a blood transfusion within the last 21 days.I have been treated with pembrolizumab or similar drugs before.I am able to get out of my bed or chair and move around.My colorectal cancer cannot be treated with standard chemotherapy.I can provide a sample of my cancer tissue that meets the size and tumor content requirements.My colorectal cancer has one of the specific gene fusions (A-D) involving RSPO2 or RSPO3.I had radiation therapy recently or still have mild side effects from it.I have had radiation treatment to my spine or pelvis.I do not have severe heart, blood pressure, diabetes, mental health issues, or serious heart rhythm problems.I cannot start treatment with bone protective drugs like denosumab or zoledronic acid.I have a wound that is not healing properly.I am not currently on antibiotics for an active infection.I have not received a COVID-19 vaccine using the ChAdOx1 method.I can swallow pills or have someone to help me take my medication.My ovarian or endometrial cancer is advanced, and regular treatments like chemotherapy are not suitable for me.I haven't had cancer treatment in the last 4 weeks or still have mild side effects from it.I last received immunotherapy more than 4 weeks ago.I have MSS endometrial cancer and haven't had immunotherapy or lenvatinib in the last 4 weeks.I have no other cancers except for treated skin cancer or cervical cancer in situ in the last 3 years.My brain cancer has been treated and stable for 8 weeks without steroids.My colorectal cancer lacks certain gene fusions.My advanced cancer is not suitable for standard treatment, and it may respond to specific new treatments.I must have tumor biopsies before and after treatment unless it's unsafe.I am a male willing to use contraception during the study and for 12 weeks after.I am using birth control and will continue for 12 weeks after treatment ends.I have moderate to severe spine fractures.My ß-CTX level is over 600 pg/mL after fasting, but not above 1000 pg/mL with treatment.I have taken diabetes medication like Actos or Avandia in the last 4 weeks.I have not had major surgery in the last 4 weeks or have recovered from surgery complications.I have taken medication for bone thinning or high calcium levels before starting the study drug.I have had fractures from falls or without injury.I have a history of long QT syndrome.I have a condition affecting my bones like hyperparathyroidism, Paget's disease, or osteomalacia.I have taken blood thinners other than low molecular weight heparin or DOACs in the last 4 weeks.I have been treated with a Wnt-B-catenin pathway inhibitor before.I have been on steroids equivalent to 10 mg of prednisone daily for the last 4 weeks.My cancer has spread to my bones.You have a disease that can be measured using the RECIST v1.1 method.I am over 18 years old (21 if in Singapore).I have a history of vasculitis.I have an autoimmune disease treated with drugs affecting my whole body in the last 2 years.I have had gastric bypass surgery in the past.There may be additional rules about who can join the study that are not listed here.I have a known bleeding or clotting disorder.You must have a hemoglobin level of at least 9 grams per deciliter.Your white blood cell count, specifically neutrophils, must be at least 1.0 billion cells per liter of blood.I have received drugs to boost my blood cells within the last 4 weeks.I am currently undergoing treatment for cancer.I have minor changes in my condition but no symptoms, and can take supplements.I have a history of specific lung conditions.My cancer has grown or spread, confirmed by recent scans.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
- Group 2: Dose Expansion
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 there room for new participants in this clinical trial?
"Data accessible via clinicaltrials.gov confirms that the trial is currently accruing patients, having been posted on October 1st 2015 and updated as recently as September 16th 2022."
Answered by AI
Has ETC-1922159 been approved by the Food and Drug Administration yet?
"Due to scant evidence of safety and efficacy, ETC-1922159 was assigned a score of 1 on our team's scale. This is reflective of the fact that this medication is undergoing its first clinical trial stage."
Answered by AI
For what treatments is ETC-1922159 commonly employed?
"ETC-1922159 is commonly used to treat malignant neoplasms and has further application for managing unresectable melanomas, microsatellite instability high, or disease progression post-chemotherapy."
Answered by AI
In what geographical areas has this research been made accessible?
"Chao Family Comprehensive Cancer Center, Stern Center for Cancer Clinical Trials and Research, University of Colorado Hospital Anschutz Cancer Pavilion, and the University of Arizona Cancer Centre are amongst the 10 sites included in this trial. Specifically located at 101 City Drive South in Orange California; 1665 Aurora Court Site 202 in Aurora Colorado; 3838 N. Campbell Avenue Site 203 in Tucson Arizona respectively ."
Answered by AI
Is it possible to review the precedent of ETC-1922159 in regards to previous medical trials?
"Currently, 122 studies for ETC-1922159 are in Phase 3 of the medical trial process. While many locations offering this research is concentrated in Houston, Texas, enquiries can be made at 35731 different sites about participating in trials for ETC-1922159."
Answered by AI
How many subjects are currently enrolled in this experimental trial?
"This trial requires 89 volunteers who meet its requisite inclusion criteria. Participants may join from either Chao Family Comprehensive Cancer Center, Stern Centre for Cancer Clinical Trials and Research (located in Orange, California), or University of Colorado Hospital Anschutz Cancer Pavilion (in Aurora, Colorado)."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger