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RecruitingLast updated: 19 September 2024

IL Believe: This study is seeking to determine the safety, effectiveness, and recommended dose level of a new cancer drug when given alone and in combination with other treatments (including immunotherapy, chemotherapy or surgery) in people with advanced or metastatic solid cancerA Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, Standard of Care Chemotherapy, or TransCon TLR7/8 Agonist, or in Combination With Pembrolizumab and Standard of Care Chemotherapy, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

Clinical summary

Summary

This trial is studying an investigational drug called TransCon IL-2 β/γ which is administered by intravenous (IV) infusion, and it will be conducted in three parts.

In Part 1, participants will receive TransCon IL-2 β/γ alone as monotherapy. TransCon IL-2 β/γ will be given in escalating doses in order to evaluate its safety and tolerability, and to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).

In Part 2, participants will receive TransCon IL-2 β/γ plus immnotherapy (called pembrolizumab) in escalating doses to evaluate its safety and tolerability, and to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). Pembrolizumab will also be administered by IV infusion.

Part 3 of this study aims to further assess the safety and tolerability, as well as the effectiveness, of the study drug TransCon IL-2 β/γ at the Recommended Phase 2 Dose level determined in the earlier parts of the study.  In this part of the study, participants will be randomly allocated to one of six treatment cohorts, who will receive different treatments:

  1. TransCon IL-2 β/γ plus standard of care chemotherapy.
  2. TransCon IL-2 β/γ plus TransCon TLR7/8 Agonist.
  3. TransCon IL-2 β/γ followed by surgery.
  4. TransCon IL-2 β/γ plus pembrolizumab followed by surgery.
  5. TransCon IL-2 β/γ with TransCon TLR7/8 Agonist followed by surgery.
  6. TransCon IL-2 β/γ with pembrolizumab and standard of care chemotherapy, followed by surgery. 

Conditions

This trial is treating patients with locally advanced or metastatic solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

IL Believe

More information

Trial Identifiers

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Trial sponsor

Ascendis Pharma Oncology Division A/S

Scientific Title

A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, Standard of Care Chemotherapy, or TransCon TLR7/8 Agonist, or in Combination With Pembrolizumab and Standard of Care Chemotherapy, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

Eligibility

Inclusion

  • At least 18 years of age
  • Demonstrated adequate organ function at screening
  • Life expectancy >12 weeks as determined by the Investigator
  • At least 1 lesion of measurable disease, except for Post Anti-PD-1 Melanoma and 2L+ Cervical Cancer (at least 2 lesions of measurable disease)
  • Female and male participants of childbearing potential who are sexually active must agree to use highly effective methods of contraception
  • Participants must have histologically confirmed locally advanced, recurrent, or metastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy), with the exception of the neoadjuvant cohorts
  • Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Part 3: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Part 1 and Part 2: Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody must have a washout of at least 4 weeks from the last dose and evidence of disease progression per investigator assessment before Cycle 1 Day 1 (C1D1)
  • Part 1 and Part 2: Participants who have previously received an immunotherapy prior to C1D1 must have any immune-related toxicities resolved to ≤Grade 1 or baseline (prior to the immunotherapy) to be eligible, with the exception of participants on well controlled physiologic endocrine replacement
  • Part 3: Part 3, neoadjuvant cohorts: participants must have completely resectable disease

Exclusion

  • Symptomatic central nervous system metastases
  • Active autoimmune diseases, regardless of need for immunosuppressive treatment, with the exception of participants well controlled on physiologic endocrine replacement
  • Any uncontrolled bacterial, fungal, viral, or other infection
  • Significant cardiac disease
  • A marked clinically significant baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 ms) [CTCAE Grade 1]) using Fridericia's QT correction formula
  • Positive for HIV or has known active hepatitis B or C infection
  • Known hypersensitivity to any study treatment(s) used in the specific study part/cohort
  • Participants who have been previously treated with IL-2 or IL-2 variants (all participants), or TLR agonist (Part 3 only for Post Anti-PD-1 Melanoma, 2L+ Cervical Cancer, and Neoadjuvant Melanoma)
  • Systemic immunosuppressive treatment with the exception for patients on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation).
  • Vaccination with live, attenuated vaccines within 4 weeks of C1D1
  • Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of C1D1
  • Part 3: Other active malignancies within the last 2 years
  • Women who are breastfeeding or have a positive serum pregnancy test during screening

Inclusion

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

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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