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RecruitingLast updated: 3 April 2024

TCTLR: This Phase I/II trial is trying to evaluate how safe and tolerable a new cancer drug (TransCon TLR7/8 Agonist) alone, and in combination with immunotherapy (Pembrolizumab) in people with advanced or metastatic solid cancersPhase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

Clinical summary

Summary

This is a non-randomised, open-label trial deigned to evaluate a new investigational drug (TransCon TLR7/8 Agonist) as monotherapy or in combination with pembrolizumab in dose escalation and dose expansion. Participants will receive an intratumoral (IT) injection of TransCon TLR7/8 Agonist every cycle. In Part 1 (Dose Escalation), participants will receive TransCon TLR7/8 Agonist monotherapy in escalating doses to evaluate safety and tolerability and to determine the MTD and RP2D. In Part 2 (dose escalation), participants will receive TransCon TLR7/8 Agonist in combination with pembrolizumab (administered intravenously [IV]) to evaluate safety/tolerability and determine the MTD and RP2D. In Part 3 (Dose Expansion), participants will receive TransCon TLR7/8 Agonist in combination with pembrolizumab using the RP2D from part 2 to evaluate the safety/tolerability and anti-tumour activity of the combined treatment.

Conditions

This trial is treating patients with solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

TCTLR

More information

Trial Identifiers

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Trial sponsor

Ascendis Pharma Oncology Division A/S

Scientific Title

Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

Eligibility

Inclusion

  • At least 18 years of age.
  • Participants must have histologically confirmed locally advanced, recurrent or metastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy).
  • Participants must have progressed on or be intolerant of available standard of care treatment options or have disease for which there is no standard of care treatment available, with the exception of participants enrolling to the neoadjuvant cohorts.
  • At least 2 lesions of measurable disease, unless specified otherwise in the selection criteria.
  • Willingness to undergo biopsies.
  • Demonstrated adequate organ function within 28 days of Cycle 1 Day 1 (C1D1).
  • Life expectancy >12 weeks as determined by the Investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or antiCTLA 4 antibody must have at least 4 weeks from the last dose of antibody and evidence of disease progression per investigator assessment before enrollment.
  • Participants who have previously received an immune checkpoint inhibitor prior to enrollment must have any immune related toxicities resolved to ≤Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible.
  • Female and male participants of childbearing potential who are sexually active must agree to use highly effective methods of contraception.

Exclusion

  • Participants who have been previously treated with a TLR agonist (excluding topical agents for unrelated disease) are not eligible.
  • Other active malignancies within the last 2 years are excluded.
  • Active autoimmune diseases, regardless of need for immunosuppressive treatment at the time of screening, with the exception of patients well controlled on physiologic endocrine replacement.
  • Systemic immunosuppressive treatment with the exception for patients on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation). Participants cannot start dosing on study until steroid dose is at or lower than 10 mg per day prednisone or equivalent.
  • Women who are breastfeeding or have a positive serum pregnancy test during screening or within 72 hours prior to C1D1 are not eligible.
  • Vaccination with live, attenuated vaccines within 4 weeks of enrollment.
  • Symptomatic central nervous system metastases.
  • Known bleeding disorder that is deemed to place the patient at unacceptable risk for bleeding complications from intratumoral injections or biopsies.
  • Known hypersensitivity to any component of TransCon TLR7/8 Agonist or pembrolizumab.
  • Any uncontrolled bacterial, fungal, viral, or other infection.
  • Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of first dosing on study is not allowed.
  • Significant cardiac disease
  • A marked baseline prolongation of QT/QTc (corrected QT) interval (e.g., repeated demonstration of a QTc interval >480 ms (National Cancer Institute NCI) Common Terminology Criteria for Adverse Events [CTCAE] grade 1) using Fredericia's QT correction formula.
  • A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, clinically significant hypokalemia, family history of Long QT Syndrome).
  • The use of concomitant medications that prolong the QT/QTc interval within 14 days of enrollment.
  • Positive for HIV or with active hepatitis B or C infection.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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