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Trial · Interventional

CompletedPhase 1Registry data

LTX-315 in Patients With Transdermally Accessible Tumours as Monotherapy or Combination With Ipilimumab or Pembrolizumab

Overview

Status
Completed
Phase
Phase 1
Enrollment
80 participants (estimated)
Sponsor
Lytix Biopharma AS · Industry
Design
Not randomized · Open label (no masking)
Countries
5 countries

Belgium, France, Italy, Norway, United Kingdom

Start
Nov 2013
Primary completion
Apr 2018
Completion
31 Aug 2018
First posted
18 Nov 2013 (estimated)
Last update posted
3 Oct 2018
Conditions
Cancer · Melanoma · Breast Cancer · Head and Neck Cancer · Lymphoma · Triple-Negative Breast Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016201720182019
  1. Ph 1

    LTX-315 in Patients With Transdermally Accessible Tumours as Monotherapy or Combination With Ipilimumab or Pembrolizumab

    NCT01986426

    Nov 2013 to 31 Aug 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The study will assess the safety, tolerability, PK and efficacy of different intra-tumoral dosing regimens of LTX-315; a lytic-peptide that induces long-term anti-cancer immune responses, as monotherapy or in combination with ipilimumab or pembrolizumab.

Interventions

  • LTX-315 consecutive lesionsDrug
  • LTX-315Drug
  • LTX-315 + ipilimumabDrug
  • LTX-315 + pembrolizumabDrug

Arms4

  • Experimental

    Arm A: LTX-315 monotherapy singe lesion

    Cohort 1-3: First induction treatment (6 weeks): In week 1 the first index lesion will be injected Twice daily on 3 consecutive days. During week 2-6 the injection will be once a week. Second induction treatment (6 weeks) and Maintenance treatment (20 weeks)- At week 7 the second index lesion will be injected with same dosing schedule as the first index lesion. Cohort 4 and above: Once daily on 3 consecutive days week 1. Week 2-6 one injection per week. From week 8, one dosing days every 2 weeks.

  • Experimental

    Arm B: LTX-315 monotherapy in multiple concurrent lesions

    Patients with at least one injectable lesion and one bystander lesion will receive LTX-315 to one or more lesions: Once daily on 2 consecutive days week 1-3.

  • Experimental

    Arm C

    Patients with melanoma and at least one injectable lesion will receive LTX-315 to one or more lesions on two consecutive days week 1-3 in combination with ipilimumab given for 4 cycles every 3 weeks.

  • Experimental

    Arm D

    Patients with TNBC and at least one injectable lesion will receive LTX-315 to one or more lesions on two consecutive days week 1-3 in combination with pembrolizumab given every 3 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Dose limiting toxicity

    Time frame · 21 days

    Registry description

    Dose limiting toxicities (DLT) and the overall safety profile (adverse events (AE), laboratory assessments, physical findings and symptomatic assessment) of LTX-315 as monotherapy and in combination with ipilimumab or pembrolizumab.

Secondary outcomes(5)
  1. Anti tumour activity in injected tumour

    Time frame · Every 8 weeks from treatment start up to 24 months or first documented progression documented assessed

    Registry description

    Number of patients with regression of injected tumour assessed by ultrasound and/or CT/MRI.

  2. Complete response (irCR) and partial response (irPR)

    Time frame · Every 8 weeks from treatment start up to 24 months or first documented progression documented assessed

    Registry description

    Number of patients by irRC

  3. Overall response rate (OR)

    Time frame · Every 8 weeks from treatment start up to 24 months or first documented progression documented assessed

    Registry description

    (irRC criteria)

  4. Disease control rate (CR + PR + SD)

    Time frame · Every 8 weeks from treatment start up to 24 months or first documented progression documented assessed

    Registry description

    irRC criteria

  5. Progression free survival (PFS)

    Time frame · Every 8 weeks from treatment start up to 24 months or first documented progression documented assessed

    Registry description

    irRC criteria

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Clinical trial · 2021

12 results

Safety, Antitumor Activity, and T-cell Responses in a Dose-Ranging Phase I Trial of the Oncolytic Peptide LTX-315 in Patients with Solid Tumors.

Spicer et al. 2021Clinical cancer research : an official journal of the American Association for Cancer Researchcited by 63

PMID 33542073DOI 10.1158/1078-0432.ccr-20-3435PUB-33542073

Rights unknown12 results

Indexing hint: Case report · 2019

5 results

Enhanced T-lymphocyte infiltration in a desmoid tumor of the thoracic wall in a young woman treated with intratumoral injections of the oncolytic peptide LTX-315: a case report.

Jebsen et al. 2019Journal of medical case reportscited by 14

PMID 31177991PMC6556957DOI 10.1186/s13256-019-2088-6PUB-31177991

CC BY5 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Arm A: (Recruitment completed) Arm B: * Unresectable metastatic disease (any tumor type) and conventional anti-tumor treatment is not appropriate. * Have at least one available lesion (cutaneous, sub-cutaneous, oral or lymph node) for injection between 1-3 cm longest diameter and one bystander lesion (non-injected). Arm C: * Have unresectable/metastatic diagnosis of malignant melanoma (histologically confirmed). * Have at least one available lesion (cutaneous, sub-cutaneous, oral or lymph node) for injection and biopsy which is between 1 and 3 cm in longest diameter. * Have had previous treatment with an anti-PD-1 antibody (as monotherapy or as part of combination (any combination) as 1st or 2nd line metastatic treatment). Arm D: * Have unresectable/metastatic diagnosis of triple negative breast cancer (histologically confirmed). * Have at least one available lesion (cutaneous, sub-cutaneous or lymph node) for injection and biopsy with a minimum longest diameter of 1 cm. * Have received between one and 4 prior systemic treatments for metastatic triple negative breast cancer. All arms: * Be willing to undergo repeat tumour biopsy and/or tumour resection procedures. * Have an ECOG Performance status (PS): 0 - 1. * Meet the following laboratory requirements: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L 2. Absolute lymphocyte count ≥ 0.8 x 109/L 3. Platelet count ≥ 75 x 109/L 4. Haemoglobin ≥ 9.0 g/dL 5. aPTT/PT within the institution's normal range 6. Total bilirubin level ≤ 1.5 x ULN 7. ASAT and ALAT ≤ 2.5 x ULN (≤5 x ULN if liver metastasis present) 8. Creatinine ≤ 1.5 x ULN 9. Albumin ≥ 30 g/L Exclusion Criteria: Arm A: (Completed) Arm B: * Have a history of systemic auto-immune disease requiring anti-inflammatory or immunosuppressive therapy within the last 3 months. Patients with history of autoimmune thyroiditis are eligible provided the patient requires only thyroid hormone replacement therapy and disease has been stable for ≥ 1 year. Arm C: * Have had prior therapy with ipilimumab or any other anti-CTLA-4 monoclonal antibody. * Have had BRAF/MEK inhibitors administered within 2 weeks prior to the study drug administration. * Have active systemic autoimmune disease; have had prior pneumonitis; have a history of severe hypersensitivity to another monoclonal antibody; are receiving immunosuppressive therapy; have a history of severe immune-related adverse reaction from treatment with a monoclonal antibody, defined as any Grade 4 or 3 toxicity requiring corticosteroid treatment (\> 10 mg/day prednisone or equivalent) for greater than 12 weeks. Arm D: * Have had prior therapy with an anti-PD-1 or anti-PD-L1 monoclonal antibody. * Have received cancer immunotherapy within 2 weeks prior to study drug administration or have not recovered from adverse events (to ≤ CTCAE grade 1) due to such agents. * Have active systemic autoimmune disease; have had prior pneumonitis; have a history of severe hypersensitivity to another monoclonal antibody; are receiving immunosuppressive therapy; and have a history of severe immune-related adverse reactions from treatment with a monoclonal antibody, defined as any Grade 4 or 3 toxicity requiring corticosteroid treatment (\> 10 mg/day prednisone or equivalent) for greater than 12 weeks. All arms: * Have received external radiotherapy or cytotoxic chemotherapy within 4 weeks prior to study drug administration, or have not recovered from adverse events (≤ CTCAE grade 1) due to agents administered more than 4 weeks earlier. Palliative radiotherapy to non-target lesions within 4 weeks prior to study drug administration is allowed. * Are currently taking any agent with a known effect on the immune system. Patients are allowed to be on a stable dose of corticosteroids (up to 10 mg daily prednisolone or equivalent) for at least 2 weeks prior to study drug administration (please see Appendix IV for prohibited medications). * Have any other serious illness or medical condition such as, but not limited to: 1. Uncontrolled infection or infection requiring antibiotics 2. Uncontrolled cardiac failure: Classification III or IV (New York Heart Association) 3. Uncontrolled systemic and gastro-intestinal inflammatory conditions 4. Bone marrow dysplasia * Have a known history of positive tests for HIV/AIDS, or have active hepatitis B or C (based on serology). * Are expected to need any other anti-cancer therapy or immunotherapy to be initiated during the study period. 15\. Have clinically active or unstable CNS metastases as assessed by the treating physician.

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