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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT04672434

NCT04672434
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You are 18 years of age or older
  • You have been diagnosed (confirmed by biopsy or lab test) with an advanced or metastatic solid tumor that is one of the following: squamous cell carcinoma of the head and neck, non-small-cell lung cancer (adenocarcinoma type), pancreatic ductal adenocarcinoma, cholangiocarcinoma (bile duct cancer), colorectal cancer, gastric (stomach) or gastroesophageal cancer, esophageal cancer, mesothelioma (pleural or peritoneal), or cervical cancer
  • Your cancer cannot be removed by surgery, either because surgery is not medically safe for you or because the tumor cannot be fully removed
  • Your cancer can be measured on scans according to specific guidelines (called RECIST v1.1)
  • Your cancer has stopped responding to, or you could not tolerate, existing treatments that are known to help
  • You are willing to have two tumor tissue biopsies (small tissue samples taken from the tumor) during the trial
  • You are generally well enough to carry out light activity and care for yourself (confirm with trial site what this means for your situation)
  • Your liver, kidneys, and other organs are functioning well enough as shown by blood tests
  • You are willing and able to use appropriate contraception if required

Who may not be able to join:

  • You have cancer that has spread to the brain or spinal cord
  • You have a significant heart or blood vessel disease or condition
  • You have an active blood clot, or have had a deep vein thrombosis (blood clot in a vein) or a pulmonary embolism (blood clot in the lungs) within the past 4 weeks
  • You have active, uncontrolled bleeding or a known problem with blood clotting
  • You have a significant eye disease or condition
  • You have a significant lung disease or condition (beyond your cancer)
  • You have had a significant digestive system (stomach or bowel) disease or condition within the past 6 months
  • You have an active or suspected autoimmune disease (where the immune system attacks the body)
  • You have previously had an organ transplant or stem cell transplant
  • You have a known history of HIV, or an active hepatitis B or hepatitis C infection
  • You have any other serious or uncontrolled infection
  • You have previously had serious side effects from immune checkpoint inhibitor treatments
  • You have a known allergy or sensitivity to any ingredients in the study drugs
  • You still have side effects from a previous cancer treatment that are more than mild in severity
  • You have not fully recovered from a recent surgery, or you have had a major surgery within the past 4 weeks
  • You have any other serious, life-threatening, or unstable medical condition unrelated to your cancer
  • You have previously been treated with Sym024 or certain other drugs that target specific immune pathways (CD73, CD39, or adenosine receptors) (confirm with trial site)
  • In certain parts of the trial, you may not be eligible if you have had previous immunotherapy treatment, unless it was an approved treatment for your specific cancer type (confirm with trial site)
  • You have received any cancer treatment (standard or experimental) within the past 4 weeks or 5 half-lives of the drug (confirm with trial site)
  • You have taken part in another experimental treatment study within the past 2 weeks
  • You have received certain types of radiotherapy recently (confirm with trial site for details)
  • You have received a live vaccine within the past 4 weeks
  • You have been taking immune-suppressing medications or high-dose steroid medications within the past 2 weeks (with some exceptions — confirm with trial site)
  • You have received certain blood cell-boosting medications (hematopoietic growth factors) within the past week

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
Symphogen A/S
Registry
clinicaltrials_gov
Start date
19 November 2020
Est. completion
22 November 2024

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

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.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov