Study · Non-randomized trial · n = 39 · 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 J, Marabelle A, Baurain JF, Jebsen NL, Jøssang DE, Awada A, Kristeleit R, Loirat D, Lazaridis G, Jungels C, Brunsvig P, Nicolaisen B and 9 more

Show all authors

Saunders A, Patel H, Galon J, Hermitte F, Camilio KA, Mauseth B, Sundvold V, Sveinbjørnsson B, Rekdal Ø

Clinical cancer research : an official journal of the American Association for Cancer Research4 Feb 2021Cited by 63 (Europe PMC)

PMID33542073DOI10.1158/1078-0432.ccr-20-3435PepBankPUB-33542073

Source link PubMedAsk about this study

Jump to 12 results

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study12

12 results from studies that gave the peptide. 12 results from people.

01HumanNon-randomized trialSafety outcome
In patients with solid tumors, treatment-related grade 1-2 transient hypotension occurred in 18 patients (46%) receiving LTX‑315.
In plain wordsIn patients with solid tumors, transient low blood pressure occurred in 46% during LTX‑315 treatment.
Peptide
LTX-315
Outcome
Direction not reportedTransient hypotension
Study
n = 39
Analysis
Primary
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated · intratumoralAs given in this study (human).
Measurements
Patients
18 patients
transient hypotension
Incidence
46%
transient hypotension
Source sentences
Summary
The most common treatment-related grade 1-2 adverse events were vascular disorders including transient hypotension (18 patients, 46%), flushing (11 patients, 28%), and injection site reactions in 38% of patients.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase I dose-escalating study of intratumoral LTX-315 administration in patients with advanced solid tumors.
Report a problemFND-3354207301
02HumanNon-randomized trialSafety outcome
In patients with solid tumors, treatment-related grade 1-2 flushing occurred in 11 patients (28%) receiving LTX‑315.
In plain wordsIn patients with solid tumors, flushing occurred in 28% during LTX‑315 treatment.
Peptide
LTX-315
Outcome
Direction not reportedFlushing
Study
n = 39
Analysis
Primary
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated · intratumoralAs given in this study (human).
Measurements
Patients
11 patients
flushing
Incidence
28%
flushing
Source sentences
Summary
The most common treatment-related grade 1-2 adverse events were vascular disorders including transient hypotension (18 patients, 46%), flushing (11 patients, 28%), and injection site reactions in 38% of patients.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase I dose-escalating study of intratumoral LTX-315 administration in patients with advanced solid tumors.
Report a problemFND-3354207302
03HumanNon-randomized trialSafety outcome
In patients with solid tumors, treatment-related grade 1-2 injection site reactions occurred in 38% receiving LTX‑315.
In plain wordsIn patients with solid tumors, injection site reactions occurred in 38% during LTX‑315 treatment.
Peptide
LTX-315
Outcome
Direction not reportedInjection site reactions
Study
n = 39
Analysis
Primary
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated · intratumoralAs given in this study (human).
Measurements
Incidence
38%
injection site reactions
Source sentences
Summary
The most common treatment-related grade 1-2 adverse events were vascular disorders including transient hypotension (18 patients, 46%), flushing (11 patients, 28%), and injection site reactions in 38% of patients.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase I dose-escalating study of intratumoral LTX-315 administration in patients with advanced solid tumors.
Report a problemFND-3354207303
04HumanNon-randomized trialSafety outcome
In patients with solid tumors, grade 3 LTX‑315-related hypersensitivity or anaphylaxis occurred in 4 patients (10%).
In plain wordsIn patients with solid tumors, severe hypersensitivity or anaphylaxis occurred in 10% during LTX‑315 treatment.
Peptide
LTX-315
Outcome
Direction not reportedHypersensitivity or anaphylaxis
Study
n = 39
Analysis
Primary
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated · intratumoralAs given in this study (human).
Measurements
Patients
4 patients
hypersensitivity or anaphylaxis
Incidence
10%
hypersensitivity or anaphylaxis
Source sentences
Summary
The most common grade 3 LTX-315-related toxicities were hypersensitivity or anaphylaxis (4 patients, 10%).
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase I dose-escalating study of intratumoral LTX-315 administration in patients with advanced solid tumors.
Report a problemFND-3354207304
05HumanNon-randomized trialMechanism
In patients with solid tumors, serial biopsies indicated that LTX‑315 induced tumor necrosis.
In plain wordsIn patients with solid tumors, biopsies showed tumor tissue death after LTX‑315 treatment.
Peptide
LTX-315
Outcome
IncreaseTumor necrosis
Study
n: not reported in source
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · intratumoralAs given in this study (human).
Source sentences
Summary
Analysis of immune endpoints in serial biopsies indicated that LTX-315 induces necrosis and CD8⁺ T-cell infiltration into the tumor microenvironment.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase I dose-escalating study of intratumoral LTX-315 administration in patients with advanced solid tumors.
Report a problemFND-3354207305
06HumanNon-randomized trialMechanism
In patients with solid tumors, serial biopsies indicated that LTX‑315 induced tumor CD8+ T-cell infiltration.
In plain wordsIn patients with solid tumors, biopsies showed CD8+ T-cell entry into tumors after LTX‑315 treatment.
Peptide
LTX-315
Outcome
IncreaseTumor CD8+ T-cell infiltration
Study
n: not reported in source
Analysis
Secondary
Outcome group
Immune response · Cancer
Studied dose
Dose not stated · intratumoralAs given in this study (human).
Source sentences
Summary
Analysis of immune endpoints in serial biopsies indicated that LTX-315 induces necrosis and CD8⁺ T-cell infiltration into the tumor microenvironment.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase I dose-escalating study of intratumoral LTX-315 administration in patients with advanced solid tumors.
Report a problemFND-3354207306
07HumanNon-randomized trialMechanism
In patients with solid tumors, peripheral T-cell clones expanded significantly after LTX‑315 treatment.
In plain wordsIn patients with solid tumors, blood T-cell clones expanded after LTX‑315 treatment.
Peptide
LTX-315
Outcome
IncreasePeripheral T-cell clone expansion
Study
n: not reported in source
Analysis
Secondary
Outcome group
Immune response · Cancer
Studied dose
Dose not stated · intratumoralAs given in this study (human).
Source sentences
Summary
Sequencing of the T-cell receptor repertoire in peripheral blood identified significant expansion of T-cell clones after treatment, of which 49% were present in available tumor biopsies after treatment, suggesting that they were tumor associated.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase I dose-escalating study of intratumoral LTX-315 administration in patients with advanced solid tumors.
Report a problemFND-3354207307
08HumanNon-randomized trialMechanism
In patients with solid tumors, 49% of expanded peripheral T-cell clones were present in available posttreatment tumor biopsies.
In plain wordsIn patients with solid tumors, 49% of expanded blood T-cell clones appeared in available tumor biopsies after treatment.
Peptide
LTX-315
Outcome
Direction not reportedExpanded clones present in tumors
Study
n: not reported in source
Analysis
Secondary
Outcome group
Immune response · Cancer
Studied dose
Dose not stated · intratumoralAs given in this study (human).
Measurements
Expanded clones present in tumor
49%
available posttreatment biopsies
Source sentences
Summary
Sequencing of the T-cell receptor repertoire in peripheral blood identified significant expansion of T-cell clones after treatment, of which 49% were present in available tumor biopsies after treatment, suggesting that they were tumor associated.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase I dose-escalating study of intratumoral LTX-315 administration in patients with advanced solid tumors.
Report a problemFND-3354207308
09HumanNon-randomized trialEfficacy outcome
In patients with solid tumors, injected tumor volume fell by at least 30% in 29% of patients receiving LTX‑315.
In plain wordsIn patients with solid tumors, 29% had injected tumors shrink by at least 30% after LTX‑315.
Peptide
LTX-315
Outcome
DecreaseInjected tumor volume reduction
Study
n: not reported in source
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · intratumoralAs given in this study (human).
Measurements
Responder proportion
29%
tumor volume reduction ≥30%
Source sentences
Summary
Substantial volume reduction (≥30%) of injected tumors occurred in 29% of the patients
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase I dose-escalating study of intratumoral LTX-315 administration in patients with advanced solid tumors.
Report a problemFND-3354207309
10HumanNon-randomized trialMechanism
In patients with solid tumors, intralesional CD8+ T cells increased after LTX‑315 in 86% of evaluated biopsies (12/14).
In plain wordsIn patients with solid tumors, 86% of evaluated biopsies showed more CD8+ T cells after LTX‑315.
Peptide
LTX-315
Outcome
IncreaseIntralesional CD8+ T-cell increase
Study
n: not reported in source
Analysis
Secondary
Outcome group
Immune response · Cancer
Studied dose
Dose not stated · intratumoralAs given in this study (human).
Measurements
Biopsies with increase
86%
posttreatment
Biopsies with increase
12 biopsies
of 14 evaluated biopsies, posttreatment
Source sentences
Summary
86% (12/14 biopsies) had an increase in intralesional CD8⁺ T cells posttreatment.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase I dose-escalating study of intratumoral LTX-315 administration in patients with advanced solid tumors.
Report a problemFND-3354207310
11HumanNon-randomized trialEfficacy outcome
In patients with solid tumors, no partial responses by immune-related response criteria occurred with LTX‑315.
In plain wordsIn patients with solid tumors, no partial responses occurred by immune-related response criteria after LTX‑315.
Peptide
LTX-315
Outcome
Direction not reportedPartial response
Study
n: not reported in source
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · intratumoralAs given in this study (human).
Source sentences
Summary
No partial responses by immune-related response criteria were seen
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase I dose-escalating study of intratumoral LTX-315 administration in patients with advanced solid tumors.
Report a problemFND-3354207311
12HumanNon-randomized trialEfficacy outcome
In patients with solid tumors, evidence of an abscopal effect appeared after LTX‑315 treatment.
In plain wordsIn patients with solid tumors, evidence of an effect beyond injected tumors appeared after LTX‑315 treatment.
Peptide
LTX-315
Outcome
Direction not reportedAbscopal effect
Study
n: not reported in source
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · intratumoralAs given in this study (human).
Source sentences
Summary
evidence of abscopal effect was demonstrated following treatment with LTX-315.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase I dose-escalating study of intratumoral LTX-315 administration in patients with advanced solid tumors.
Report a problemFND-3354207312

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT04796194

Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Advanced Melanoma

Lytix Biopharma ASn = 235 Nov 2021 to 1 Jul 2025

Advanced Melanoma

Trial page ClinicalTrials.govUpdated 10 Sept 2026

CompletedPhase 1NCT01986426

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

Lytix Biopharma ASn = 80Nov 2013 to 31 Aug 2018

Cancer · Melanoma · Breast Cancer · Head and Neck Cancer · Lymphoma · Triple-Negative Breast Cancer

Trial page ClinicalTrials.govUpdated 3 Oct 2018

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
27 Oct 2026, 18:20 UTC
Study results updated
Version 1
27 Oct 2026, 16:32 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.