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Monoclonal Antibodies

Sym024 and Sym021 for Solid Tumors

Phase 1
Waitlist Available
Led By N. Lakhani, MD PhD
Research Sponsored by Symphogen A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pancreatic ductal adenocarcinoma
Squamous cell carcinoma of the head and neck
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective when used alone or with another new cancer drug.

Who is the study for?
Adults with advanced solid tumors that can't be removed by surgery or have not responded to other treatments. Specific cancers include squamous cell carcinoma of the head and neck, pancreatic cancer, cholangiocarcinoma, colorectal cancer (MSS/MSI-H), gastric/esophageal/cervical carcinomas, non-small-cell lung carcinoma-adenocarcinoma subtype, and mesothelioma. Participants must have measurable disease, an ECOG performance status of 0 or 1 indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work of a light nature, adequate organ function and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing Sym024 alone and combined with Sym021 for safety and tolerability in treating various types of solid tumor malignancies. The study will assess how patients' bodies react to these drugs when taken individually or together.See study design
What are the potential side effects?
While specific side effects for Sym024 and Sym021 aren't listed here, common side effects from similar cancer therapies may include fatigue, nausea, diarrhea, skin reactions at the injection site, potential immune-related issues such as inflammation in different parts of the body like lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with pancreatic cancer.
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I have squamous cell cancer in my head or neck.
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I have been diagnosed with mesothelioma.
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I agree to have two tumor tissue biopsies.
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My cancer cannot be removed by surgery due to health reasons or because the tumor can't be taken out.
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You have been diagnosed with a specific type of advanced or metastatic cancer, and the tumor cannot be removed with surgery. You have measurable cancer according to certain guidelines, and have not benefited from previous treatments or cannot tolerate them. You are willing to have two tissue biopsies and have good overall health. You must also use appropriate contraception.
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I have been diagnosed with stomach or gastroesophageal cancer.
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My cancer is advanced or has spread, and it's one of the specified types.
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I have been diagnosed with esophageal cancer.
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I have cervical cancer, including any subtype.
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My colorectal cancer is either MSS or MSI-H.
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My condition did not improve with current treatments.
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My lung cancer is of the adenocarcinoma type.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part I: To evaluate the incidence, severity and relationship of (S)AEs to establish the MTD/MAD of Sym024 monotherapy.
Part II: To evaluate the incidence, severity and relationship of (S)AEs to establish MTD/MAD of Sym024 in combination with Sym021.
Part III: To evaluate the incidence, severity and relationship of (S)AEs to further assess safety of Sym024 when administered alone or in combination with Sym021.
Secondary outcome measures
Area under the concentration-time curve in a dosing interval (AUC)
Clearance (CL)
Evaluation of objective response (OR) or stable disease (SD)
+6 more

Trial Design

11Treatment groups
Experimental Treatment
Group I: Sym024 Dose Level 4Experimental Treatment1 Intervention
Part I, Sym024 monotherapy dose level 4
Group II: Sym024 Dose Level 3Experimental Treatment1 Intervention
Part I, Sym024 monotherapy dose level 3
Group III: Sym024 Dose Level 2Experimental Treatment1 Intervention
Part I, Sym024 monotherapy dose level 2
Group IV: Sym024 Dose Level 1Experimental Treatment1 Intervention
Part I, Sym024 monotherapy dose level 1
Group V: Sym024 Dose Level -1Experimental Treatment1 Intervention
Part I, Sym024 monotherapy dose level -1. Evaluate only if needed based on tolerability
Group VI: Sym021+Sym024 Dose Level 5Experimental Treatment2 Interventions
Part IIa, Sym024 monotherapy and in combination with Sym021
Group VII: Sym021+Sym024 Dose Level 4Experimental Treatment2 Interventions
Part II, Sym021 in combination with dose level 4 of Sym024
Group VIII: Sym021+Sym024 Dose Level 3Experimental Treatment2 Interventions
Part II, Sym021 in combination with dose level 3 of Sym024
Group IX: Sym021+Sym024 Dose Level 2Experimental Treatment2 Interventions
Part II, Sym021 in combination with dose level 2 of Sym024
Group X: Sym021+Sym024 Dose Level 1Experimental Treatment2 Interventions
Part II, Sym021 in combination with dose level 1 of Sym024. Evaluate only if needed based on tolerability
Group XI: Dose Expansion Sym021 (+Sym024)Experimental Treatment2 Interventions
Part III, dose expansion Sym024 and/or Sym021+Sym024
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sym021
2017
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

Symphogen A/SLead Sponsor
16 Previous Clinical Trials
802 Total Patients Enrolled
N. Lakhani, MD PhDPrincipal InvestigatorSTART Midwest, USA

Media Library

Cancer Research Study Groups: Dose Expansion Sym021 (+Sym024), Sym021+Sym024 Dose Level 1, Sym024 Dose Level 1, Sym024 Dose Level 2, Sym024 Dose Level 3, Sym024 Dose Level 4, Sym024 Dose Level -1, Sym021+Sym024 Dose Level 2, Sym021+Sym024 Dose Level 3, Sym021+Sym024 Dose Level 4, Sym021+Sym024 Dose Level 5

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaging in this clinical investigation?

"This study necessitates the recruitment of 100 individuals, who meet the pre-defined inclusion criteria. Specifically, patients can join this trial at NEXT Oncology in San Antonio, Texas or MD Anderson Cancer Center in Houston, Ontario."

Answered by AI

How many venues are offering this trial's services?

"At present, this clinical trial is accepting patients from 4 sites. Patients can find these centres in San Antonio, Houston, Toronto and several other cities. It would be prudent to opt for the location closest to you so as to limit travel requirements if partaking in the study."

Answered by AI

Does Sym024 have the endorsement of federal drug regulators?

"The safety of Sym024 was given a rating of 1 due to the limited data available in Phase 1 trials, which only provides some evidence for efficacy and safety."

Answered by AI

Is enrollment for this clinical trial available at the moment?

"As per the clinicaltrials.gov portal, this medical experiment is presently accepting patients with an initial posting date of November 19th 2020 and most recent update from July 7th 2022."

Answered by AI

What are the fundamental goals of this trial?

"The purpose of this 28-day clinical trial is to identify the Maximum Tolerated Dose (MTD) and/or Maximum Administered Dose (MAD) of Sym024 in combination with Sym021 by assessing the incidence, severity, and relation between potential Adverse Events. Secondary outcomes include measuring Area Under The Curve In A Dosage Interval (AUC), Max Concentration (Cmax), as well as Time To Progression Of Disease (TTP)."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
NEXT Oncology
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have met with Dr. Abbott and do not qualify for surgery. I have been on chemo since '22 with Dr. Challagundra having results of shrinking the tumor fro 7cm to 3cm. I have also had a 6 week radiation session w/results unknown until April 12th meeting with Dr. Lin.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies
2020. "Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04672434.
~6 spots leftby Dec 2024
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